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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 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-F50020LR
In Commercial Distribution

  • 04540778158610 ()

  • 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; 1500 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 5.0 mm
BD-F50020LR

  • Peripheral angioplasty balloon catheter, basic
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-F40020LR
In Commercial Distribution

  • 04540778158597 ()

  • 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; 1500 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 4.0 mm
BD-F40020LR

  • Peripheral angioplasty balloon catheter, basic
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-F30020LR
In Commercial Distribution

  • 04540778158573 ()

  • 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; 1500 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-F30020LR

  • Peripheral angioplasty balloon catheter, basic
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-F25020LR
In Commercial Distribution

  • 04540778158559 ()

  • 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; 1500 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.5 mm
BD-F25020LR

  • Peripheral angioplasty balloon catheter, basic
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-F20020LR
In Commercial Distribution

  • 04540778158535 ()

  • 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; 1500 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.0 mm
BD-F20020LR

  • Peripheral angioplasty balloon catheter, basic
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-F60200MR
In Commercial Distribution

  • 04540778158511 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 6.0 mm
BD-F60200MR

  • Peripheral angioplasty balloon catheter, basic
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-F50200MR
In Commercial Distribution

  • 04540778158498 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 5.0 mm
BD-F50200MR

  • Peripheral angioplasty balloon catheter, basic
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-F40200MR
In Commercial Distribution

  • 04540778158474 ()

  • 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; 200 mm
  • Balloon Diameter; 4.0 mm
BD-F40200MR

  • Peripheral angioplasty balloon catheter, basic
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-F30200MR
In Commercial Distribution

  • 04540778158450 ()

  • 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; 200 mm
  • Balloon Diameter; 3.0 mm
BD-F30200MR

  • Peripheral angioplasty balloon catheter, basic
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-F25200MR
In Commercial Distribution

  • 04540778158436 ()

  • 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; 200 mm
  • Balloon Diameter; 2.5 mm
BD-F25200MR

  • Peripheral angioplasty balloon catheter, basic
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