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

    CENTRIFUGAL PUMP SYSTEM LX/DX VERSION

    K Number: K882758 · Decision Oct 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    76
    Review Days
    100

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    Basic Information

    Device Name
    CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
    K Number
    K882758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Sarns
    Date Received
    July 5, 1988
    Decision Date
    October 13, 1988
    Product Code
    KFM
    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
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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