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

    SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)

    K Number: K915363 · Decision Jul 28, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    49
    Review Days
    609

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    Basic Information

    Device Name
    SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
    K Number
    K915363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Health Care, Ltd.
    Date Received
    November 27, 1991
    Decision Date
    July 28, 1993
    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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