BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    ShortCut

    K Number: DEN240017 · Decision Sep 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    163

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    Basic Information

    Device Name
    ShortCut
    K Number
    DEN240017
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.1254
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Pi-Cardia, Ltd.
    Date Received
    April 17, 2024
    Decision Date
    September 27, 2024
    Product Code
    SCZ
    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
    SCZ Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures