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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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R2P METACROSS RX - 04540778166417

R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-P30040ER
In Commercial Distribution

  • 04540778166417 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Proximal Shaft Diameter; 3.8 Fr
  • Distal Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 3.0 mm
BD-P30040ER

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778165076

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B20150LW
In Commercial Distribution

  • 04540778165076 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 2.0 mm
BD-B20150LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778165052

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B40120LW
In Commercial Distribution

  • 04540778165052 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 4.0 mm
BD-B40120LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778165014

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B30120LW
In Commercial Distribution

  • 04540778165014 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 3.0 mm
BD-B30120LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164970

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B20120LW
In Commercial Distribution

  • 04540778164970 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 2.0 mm
BD-B20120LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164956

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B15120LW
In Commercial Distribution

  • 04540778164956 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 1.5 mm
BD-B15120LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164918

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B35080LW
In Commercial Distribution

  • 04540778164918 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 3.5 mm
BD-B35080LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164871

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B25080LW
In Commercial Distribution

  • 04540778164871 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 2.5 mm
BD-B25080LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164833

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B15080LW
In Commercial Distribution

  • 04540778164833 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 1.5 mm
BD-B15080LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164796

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B35040LW
In Commercial Distribution

  • 04540778164796 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 3.5 mm
BD-B35040LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164772

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B30040LW
In Commercial Distribution

  • 04540778164772 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 3.0 mm
BD-B30040LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164758

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B25040LW
In Commercial Distribution

  • 04540778164758 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 2.5 mm
BD-B25040LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164710

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B15040LW
In Commercial Distribution

  • 04540778164710 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 1.5 mm
BD-B15040LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164697

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B15020LW
In Commercial Distribution

  • 04540778164697 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 1.5 mm
BD-B15020LW

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO OTW - 04540778164659

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B35200MW
In Commercial Distribution

  • 04540778164659 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.8 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 3.5 mm
BD-B35200MW

  • Peripheral angioplasty balloon catheter, basic

R2P CROSSTELLA RX - 04540778175334

R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q25100ER
In Commercial Distribution

  • 04540778175334 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 100 mm
  • Balloon Diameter; 2.5 mm
BD-Q25100ER

  • Peripheral angioplasty balloon catheter, basic

R2P CROSSTELLA RX - 04540778175310

R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q20100ER
In Commercial Distribution

  • 04540778175310 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 100 mm
  • Balloon Diameter; 2.0 mm
BD-Q20100ER

  • Peripheral angioplasty balloon catheter, basic

R2P CROSSTELLA RX - 04540778175273

R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q50080ER
In Commercial Distribution

  • 04540778175273 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 5.0 mm
BD-Q50080ER

  • Peripheral angioplasty balloon catheter, basic

R2P CROSSTELLA RX - 04540778175235

R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q30080ER
In Commercial Distribution

  • 04540778175235 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 3.0 mm
BD-Q30080ER

  • Peripheral angioplasty balloon catheter, basic

R2P CROSSTELLA RX - 04540778175198

R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q20080ER
In Commercial Distribution

  • 04540778175198 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 2.0 mm
BD-Q20080ER

  • Peripheral angioplasty balloon catheter, basic
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