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

    SYMBION CENTRIFUGAL BLOOD PUMP MODEL I

    K Number: K882129 · Decision Nov 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    2
    Review Days
    167

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    Basic Information

    Device Name
    SYMBION CENTRIFUGAL BLOOD PUMP MODEL I
    K Number
    K882129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Symbion, Inc.
    Date Received
    May 20, 1988
    Decision Date
    November 3, 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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    Other Clearances by Symbion, Inc.

    K Number Device Name
    K873474 SUTURELESS TEMPORARY EPICARDIAL PACING LEAD