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

    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

    K Number: K953564 · Decision Feb 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    144
    Same Product Code
    136
    Applicant Total
    2
    Review Days
    186

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    Basic Information

    Device Name
    MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
    K Number
    K953564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Cardiac Surgery, Medtronic, Inc.
    Date Received
    July 31, 1995
    Decision Date
    February 2, 1996
    Product Code
    DTL
    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
    DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

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