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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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CROSSTELLA RX - 04540778157538

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F50020MR
In Commercial Distribution

  • 04540778157538 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 5.0 mm
BD-F50020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157514

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F40020MR
In Commercial Distribution

  • 04540778157514 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 4.0 mm
BD-F40020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157491

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F30020MR
In Commercial Distribution

  • 04540778157491 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-F30020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157477

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F25020MR
In Commercial Distribution

  • 04540778157477 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.5 mm
BD-F25020MR

  • Peripheral angioplasty balloon catheter, basic

CROSSTELLA RX - 04540778157453

CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F20020MR
In Commercial Distribution

  • 04540778157453 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.0 mm
BD-F20020MR

  • Peripheral angioplasty balloon catheter, basic

METACROSS OTW - 04540778157439

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-L70200CW
In Commercial Distribution

  • 04540778157439 ()

  • 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; 1350 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 7.0 mm
BD-L70200CW

  • Peripheral angioplasty balloon catheter, basic

METACROSS OTW - 04540778157415

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-L60200CW
In Commercial Distribution

  • 04540778157415 ()

  • 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; 1350 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 6.0 mm
BD-L60200CW

  • Peripheral angioplasty balloon catheter, basic

METACROSS OTW - 04540778157392

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-L50200CW
In Commercial Distribution

  • 04540778157392 ()

  • 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; 1350 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 5.0 mm
BD-L50200CW

  • Peripheral angioplasty balloon catheter, basic

METACROSS OTW - 04540778157378

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-L40200CW
In Commercial Distribution

  • 04540778157378 ()

  • 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; 1350 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 4.0 mm
BD-L40200CW

  • Peripheral angioplasty balloon catheter, basic

METACROSS OTW - 04540778157354

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 ofcompatible guidewire the is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L30200CW
In Commercial Distribution

  • 04540778157354 ()

  • 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; 1350 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 3.0 mm
BD-L30200CW

  • Peripheral angioplasty balloon catheter, basic
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