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510(k) Data Aggregation

    K Number
    K220704
    Device Name
    Serranator PTA Serration Balloon Catheter
    Manufacturer
    Cagent Vascular, LLC
    Date Cleared
    2022-05-04

    (55 days)

    Product Code
    PNO
    Regulation Number
    870.1250
    Why 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
    K213728
    Device Name
    Serranator PTA Serration Balloon Catheter
    Manufacturer
    Cagent Vascular, LLC
    Date Cleared
    2021-12-15

    (19 days)

    Product Code
    PNO
    Regulation Number
    870.1250
    Why 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.
    Ask a Question
    K Number
    K203437
    Device Name
    Serranator PTA Serration Balloon Catheter
    Manufacturer
    Cagent Vascular, LLC
    Date Cleared
    2020-12-22

    (29 days)

    Product Code
    PNO
    Regulation Number
    870.1250
    Why 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.
    Ask a Question
    K Number
    K193181
    Device Name
    Serranator PTA Serration Balloon Catheter
    Manufacturer
    Cagent Vascular, LLC
    Date Cleared
    2020-04-15

    (149 days)

    Product Code
    PNO
    Regulation Number
    870.1250
    Why 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
    K163380
    Device Name
    Serranator Alto PTA Serration Balloon Catheter
    Manufacturer
    Cagent Vascular, LLC
    Date Cleared
    2017-02-13

    (74 days)

    Product Code
    PNO
    Regulation Number
    870.1250
    Why 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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