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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 - 04540778175075

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 - 04540778175051

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 - 04540778175037

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

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026509

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05050100
In Commercial Distribution

  • 04543660026509 ()
LA18-05050100

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026493

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 150mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05040150
In Commercial Distribution

  • 04543660026493 ()
LA18-05040150

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026486

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 100mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05040100
In Commercial Distribution

  • 04543660026486 ()
LA18-05040100

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026479

The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 6.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LW18-14560150
In Commercial Distribution

  • 04543660026479 ()
LW18-14560150

  • Peripheral angioplasty balloon catheter, basic

Adult Custom Pack - 00607567202993

701053325 BEQ-HMOD 70000-USA Adult Quadrox iD 701020489 BEQ-RF32 RotaFlow 701045763 Gas Filter
DATASCOPE CORP.
BEQ-TOP- 32100
Not in Commercial Distribution

  • 00607567202993 ()
701054438

  • Cardiopulmonary bypass system roller pump

Chameleon - 10884521812321

PTA Balloon Catheter with Injection Port
Mozarc Medical US LLC
CH12-40-75US
In Commercial Distribution

  • 10884521812321 ()

  • Catheter Gauge: 5.9 French
  • Outer Diameter: 12 Millimeter
  • Length: 40 Millimeter
  • Shaft Length, 75, CM;


  • Peripheral angioplasty balloon catheter, basic

Chameleon - 10884521812314

PTA Balloon Catheter with Injection Port
Mozarc Medical US LLC
CH10-40-75US
In Commercial Distribution

  • 10884521812314 ()

  • Outer Diameter: 10 Millimeter
  • Catheter Gauge: 5.9 French
  • Shaft Length, 75, CM;
  • Length: 40 Millimeter


  • Peripheral angioplasty balloon catheter, basic
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