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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 as described in the Indication for Use statement. The Serranator® has a nylon semi-compliant balloon with two embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0682-20040
In Commercial Distribution

  • 00852495008494 ()

  • Balloon Diameter: 2.0 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 as described in the Indication for Use statement. The Serranator® has a nylon semi-compliant balloon with two embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
CAGENT VASCULAR, LLC
FGS-0682-20120
In Commercial Distribution

  • 00852495008487 ()

  • Balloon Diameter: 2.0 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-0346-35120
In Commercial Distribution

  • 00852495008173 ()

  • Balloon Diameter: 3.5 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-0346-35080
In Commercial Distribution

  • 00852495008166 ()

  • Balloon Diameter: 3.5 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-0346-35040
In Commercial Distribution

  • 00852495008159 ()

  • Balloon Diameter: 3.5 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-0346-30120
In Commercial Distribution

  • 00852495008142 ()

  • Balloon Diameter: 3 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-0346-30080
In Commercial Distribution

  • 00852495008135 ()

  • Balloon Diameter: 3 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-0346-25120
In Commercial Distribution

  • 00852495008111 ()

  • Balloon Diameter: 2.5 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-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-0492-60120
In Commercial Distribution

  • 00852495008081 ()

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


  • Peripheral angioplasty balloon catheter, basic
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