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

    PUMP, BYPASS, PULSATILE, AVCO

    K Number: K770937 · Decision Nov 17, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    5
    Review Days
    178

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    Basic Information

    Device Name
    PUMP, BYPASS, PULSATILE, AVCO
    K Number
    K770937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Avco Medical Products
    Date Received
    May 23, 1977
    Decision Date
    November 17, 1977
    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 Avco Medical Products

    K Number Device Name
    K802924 KONTRON PERCUTAEOUS DOUBLE-LUMEN
    K790241 INTRA-AORTIC BALLOON-PUMP
    K781848 PUMP, BALLOON MODEL 10
    K770821 PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT