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

    D·Kaptain PTA High Pressure Balloon Dilatation Catheter

    K Number: K214009 · Decision Apr 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    3
    Review Days
    516

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    Basic Information

    Device Name
    D·Kaptain PTA High Pressure Balloon Dilatation Catheter
    K Number
    K214009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dk Medical Technology Co., Ltd.
    Date Received
    November 5, 2021
    Decision Date
    April 5, 2023
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by Dk Medical Technology Co., Ltd.

    K Number Device Name
    K242254 D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter
    K232207 D·Kutting™ PTA Scoring Balloon Dilatation Catheter