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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 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-Q50060ER
In Commercial Distribution

  • 04540778175150 ()

  • 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; 60 mm
  • Balloon Diameter; 5.0 mm
BD-Q50060ER

  • Peripheral angioplasty balloon catheter, basic
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-Q40060ER
In Commercial Distribution

  • 04540778175136 ()

  • 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; 60 mm
  • Balloon Diameter; 4.0 mm
BD-Q40060ER

  • Peripheral angioplasty balloon catheter, basic
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-Q30060ER
In Commercial Distribution

  • 04540778175112 ()

  • 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; 60 mm
  • Balloon Diameter; 3.0 mm
BD-Q30060ER

  • Peripheral angioplasty balloon catheter, basic
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-Q25060ER
In Commercial Distribution

  • 04540778175099 ()

  • 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; 60 mm
  • Balloon Diameter; 2.5 mm
BD-Q25060ER

  • Peripheral angioplasty balloon catheter, basic
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-Q20060ER
In Commercial Distribution

  • 04540778175075 ()

  • 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; 60 mm
  • Balloon Diameter; 2.0 mm
BD-Q20060ER

  • Peripheral angioplasty balloon catheter, basic
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-Q60040ER
In Commercial Distribution

  • 04540778175051 ()

  • 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; 40 mm
  • Balloon Diameter; 6.0 mm
BD-Q60040ER

  • Peripheral angioplasty balloon catheter, basic
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-Q50040ER
In Commercial Distribution

  • 04540778175037 ()

  • 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; 40 mm
  • Balloon Diameter; 5.0 mm
BD-Q50040ER

  • Peripheral angioplasty balloon catheter, basic
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-Q40040ER
In Commercial Distribution

  • 04540778175013 ()

  • 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; 40 mm
  • Balloon Diameter; 4.0 mm
BD-Q40040ER

  • Peripheral angioplasty balloon catheter, basic
RX TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-RY4030UA2
In Commercial Distribution

  • 04540778168473 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 2.1 Fr
  • Distal Shaft Diameter; 2.7 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 30 mm
  • Balloon Diameter; 4.0 mm
DC-RY4030UA2

  • Coronary angioplasty balloon catheter, basic
RX TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-RY3530UA2
In Commercial Distribution

  • 04540778168459 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 2.0 Fr
  • Distal Shaft Diameter; 2.5 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 30 mm
  • Balloon Diameter; 3.5 mm
DC-RY3530UA2

  • Coronary angioplasty balloon catheter, basic
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