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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L80020MW
In Commercial Distribution

  • 04540778155398 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 8.0 mm
BD-L80020MW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L70020MW
In Commercial Distribution

  • 04540778155374 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 7.0 mm
BD-L70020MW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L60020MW
In Commercial Distribution

  • 04540778155350 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 6.0 mm
BD-L60020MW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L50020MW
In Commercial Distribution

  • 04540778155336 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 18 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 5.0 mm
BD-L50020MW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L40020MW
In Commercial Distribution

  • 04540778155312 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 4.0 mm
BD-L40020MW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L30020MW
In Commercial Distribution

  • 04540778155299 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-L30020MW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L70200SW
In Commercial Distribution

  • 04540778155275 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 7.0 mm
BD-L70200SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L60200SW
In Commercial Distribution

  • 04540778155251 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 6.0 mm
BD-L60200SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L50200SW
In Commercial Distribution

  • 04540778155237 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 18 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 5.0 mm
BD-L50200SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L40200SW
In Commercial Distribution

  • 04540778155213 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 4.0 mm
BD-L40200SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L30200SW
In Commercial Distribution

  • 04540778155190 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 3.0 mm
BD-L30200SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L70150SW
In Commercial Distribution

  • 04540778155176 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 7.0 mm
BD-L70150SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L60150SW
In Commercial Distribution

  • 04540778155152 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 6.0 mm
BD-L60150SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L50150SW
In Commercial Distribution

  • 04540778155138 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 18 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 5.0 mm
BD-L50150SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L40150SW
In Commercial Distribution

  • 04540778155114 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 4.0 mm
BD-L40150SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L30150SW
In Commercial Distribution

  • 04540778155091 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 3.0 mm
BD-L30150SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L70120SW
In Commercial Distribution

  • 04540778155077 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 7.0 mm
BD-L70120SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L60120SW
In Commercial Distribution

  • 04540778155053 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 6.0 mm
BD-L60120SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L50120SW
In Commercial Distribution

  • 04540778155039 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 18 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 5.0 mm
BD-L50120SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L40120SW
In Commercial Distribution

  • 04540778155015 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 4.0 mm
BD-L40120SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L30120SW
In Commercial Distribution

  • 04540778154995 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 3.0 mm
BD-L30120SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L70100SW
In Commercial Distribution

  • 04540778154971 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 100 mm
  • Balloon Diameter; 7.0 mm
BD-L70100SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L60100SW
In Commercial Distribution

  • 04540778154957 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 100 mm
  • Balloon Diameter; 6.0 mm
BD-L60100SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L50100SW
In Commercial Distribution

  • 04540778154933 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 18 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 100 mm
  • Balloon Diameter; 5.0 mm
BD-L50100SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L40100SW
In Commercial Distribution

  • 04540778154919 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 100 mm
  • Balloon Diameter; 4.0 mm
BD-L40100SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L30100SW
In Commercial Distribution

  • 04540778154896 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Shaft Diameter; 5.4 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 100 mm
  • Balloon Diameter; 3.0 mm
BD-L30100SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-LX0080SW
In Commercial Distribution

  • 04540778154872 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 7 Fr
  • Rated Burst Pressure; 12 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 10.0 mm
BD-LX0080SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L90080SW
In Commercial Distribution

  • 04540778154858 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 7 Fr
  • Rated Burst Pressure; 12 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 9.0 mm
BD-L90080SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L80080SW
In Commercial Distribution

  • 04540778154834 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 8.0 mm
BD-L80080SW

  • Peripheral angioplasty balloon catheter, basic
METACROSS OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L70080SW
In Commercial Distribution

  • 04540778154810 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 650 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 7.0 mm
BD-L70080SW

  • Peripheral angioplasty balloon catheter, basic
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