BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Selebrek PTCA Balloon Dilatation Catheter

    K Number: K211349 · Decision Jan 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    85
    Applicant Total
    5
    Review Days
    249

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    Basic Information

    Device Name
    Selebrek PTCA Balloon Dilatation Catheter
    K Number
    K211349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kossel Medtech (Suzhou) Co., Ltd.
    Date Received
    May 3, 2021
    Decision Date
    January 7, 2022
    Product Code
    LOX
    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
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

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    Other Clearances by Kossel Medtech (Suzhou) Co., Ltd.

    K Number Device Name
    K231402 HP PTA Balloon Dilatation Catheter
    K221245 PTA Balloon Dilatation Catheter
    K211393 Selethru(TM) NC PTCA Balloon Dilatation Catheter
    K182699 Selethru PTCA Balloon Dilatation Catheter