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Found 5 results
510(k) Data Aggregation
K Number
K220704Device Name
Serranator PTA Serration Balloon Catheter
Manufacturer
Cagent Vascular, LLC
Date Cleared
2022-05-04
(55 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Cagent Vascular, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Device Description
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 semicompliant balloon with multiple 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.
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K Number
K213728Device Name
Serranator PTA Serration Balloon Catheter
Manufacturer
Cagent Vascular, LLC
Date Cleared
2021-12-15
(19 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Cagent Vascular, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the illac, femoral, and poplited arteries for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Device Description
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 semicompliant balloon with 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.
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K Number
K203437Device Name
Serranator PTA Serration Balloon Catheter
Manufacturer
Cagent Vascular, LLC
Date Cleared
2020-12-22
(29 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Cagent Vascular, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
Device Description
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 semicompliant balloon with three 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.
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K Number
K193181Device Name
Serranator PTA Serration Balloon Catheter
Manufacturer
Cagent Vascular, LLC
Date Cleared
2020-04-15
(149 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Cagent Vascular, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
Device Description
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 semicompliant balloon with three 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.
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K Number
K163380Device Name
Serranator Alto PTA Serration Balloon Catheter
Manufacturer
Cagent Vascular, LLC
Date Cleared
2017-02-13
(74 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Cagent Vascular, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serranator™ Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Device Description
The Serranator™ Alto PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral vasculature as described in the Indications for Use statement. The Serranator™ has a nylon semi-compliant balloon with four embedded external metal strips, or scoring elements. The scoring elements are designed to create linear, interrupted scoring along the endoluminal surface that occurs during balloon angioplasty.
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