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

    LEFT VENTRICULAR VENT VALVE MODEL NO. GLV

    K Number: K862540 · Decision Aug 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    75
    Review Days
    58

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    Basic Information

    Device Name
    LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
    K Number
    K862540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4430
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Gish Biomedical, Inc.
    Date Received
    July 2, 1986
    Decision Date
    August 29, 1986
    Product Code
    DWD
    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
    DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

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