BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Serranator PTA Serration Balloon Catheter

    K Number: K203437 · Decision Dec 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    44
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    Serranator PTA Serration Balloon Catheter
    K Number
    K203437
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cagent Vascular, LLC
    Date Received
    November 23, 2020
    Decision Date
    December 22, 2020
    Product Code
    PNO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PNO Catheter, Percutaneous, Cutting/Scoring

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    Other Clearances by Cagent Vascular, LLC

    K Number Device Name
    K220704 Serranator PTA Serration Balloon Catheter
    K213728 Serranator PTA Serration Balloon Catheter
    K193181 Serranator PTA Serration Balloon Catheter
    K163380 Serranator Alto PTA Serration Balloon Catheter