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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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The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0346-25080
In Commercial Distribution

  • 00852495008104 ()

  • Balloon Diameter: 2.5 Millimeter
  • Balloon Length: 80 Millimeter


  • Peripheral angioplasty balloon catheter, basic
The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0346-25040
In Commercial Distribution

  • 00852495008098 ()

  • Balloon Diameter: 2.5 Millimeter
  • Balloon Length: 40 Millimeter


  • Peripheral angioplasty balloon catheter, basic
The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0492-60120
In Commercial Distribution

  • 00852495008081 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter


  • Peripheral angioplasty balloon catheter, basic
The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0492-60040
In Commercial Distribution

  • 00852495008067 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 40 Millimeter


  • Peripheral angioplasty balloon catheter, basic
The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0492-50120
In Commercial Distribution

  • 00852495008050 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter


  • Peripheral angioplasty balloon catheter, basic
The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0492-50040
In Commercial Distribution

  • 00852495008036 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter


  • Peripheral angioplasty balloon catheter, basic
The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0492-40120
In Commercial Distribution

  • 00852495008029 ()

  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 120 Millimeter


  • Peripheral angioplasty balloon catheter, basic
The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator® has a nylon semi- compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0492-40040
In Commercial Distribution

  • 00852495008005 ()

  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 40 Millimeter


  • Peripheral angioplasty balloon catheter, basic
The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Contego Medical, Inc.
5120x135
In Commercial Distribution

  • 00851616007538 ()
V1-5120-135-01

  • Peripheral angioplasty balloon catheter, basic
The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material
Contego Medical, Inc.
5.5.x20
In Commercial Distribution

  • 00851616007477 ()
PD-5520-140-2

  • Peripheral angioplasty balloon catheter, basic
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