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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-F25100MR
In Commercial Distribution

  • 04540778157958 ()

  • 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; 100 mm
  • Balloon Diameter; 2.5 mm
BD-F25100MR

  • 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-F20100MR
In Commercial Distribution

  • 04540778157934 ()

  • 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; 100 mm
  • Balloon Diameter; 2.0 mm
BD-F20100MR

  • 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-F60080MR
In Commercial Distribution

  • 04540778157910 ()

  • 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; 80 mm
  • Balloon Diameter; 6.0 mm
BD-F60080MR

  • 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-F50080MR
In Commercial Distribution

  • 04540778157897 ()

  • 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; 80 mm
  • Balloon Diameter; 5.0 mm
BD-F50080MR

  • 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-F40080MR
In Commercial Distribution

  • 04540778157873 ()

  • 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; 80 mm
  • Balloon Diameter; 4.0 mm
BD-F40080MR

  • 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-F30080MR
In Commercial Distribution

  • 04540778157859 ()

  • 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; 80 mm
  • Balloon Diameter; 3.0 mm
BD-F30080MR

  • 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-F25080MR
In Commercial Distribution

  • 04540778157835 ()

  • 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; 80 mm
  • Balloon Diameter; 2.5 mm
BD-F25080MR

  • 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-F20080MR
In Commercial Distribution

  • 04540778157811 ()

  • 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; 80 mm
  • Balloon Diameter; 2.0 mm
BD-F20080MR

  • 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-F60060MR
In Commercial Distribution

  • 04540778157798 ()

  • 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; 60 mm
  • Balloon Diameter; 6.0 mm
BD-F60060MR

  • 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-F50060MR
In Commercial Distribution

  • 04540778157774 ()

  • 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; 60 mm
  • Balloon Diameter; 5.0 mm
BD-F50060MR

  • Peripheral angioplasty balloon catheter, basic
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