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

    INTRA-AORTIC BALLOON-PUMP

    K Number: K790241 · Decision Feb 23, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    22

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    Basic Information

    Device Name
    INTRA-AORTIC BALLOON-PUMP
    K Number
    K790241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Avco Medical Products
    Date Received
    February 1, 1979
    Decision Date
    February 23, 1979
    Product Code
    DSP
    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
    DSP System, Balloon, Intra-Aortic And Control

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    Other Clearances by Avco Medical Products

    K Number Device Name
    K802924 KONTRON PERCUTAEOUS DOUBLE-LUMEN
    K781848 PUMP, BALLOON MODEL 10
    K770937 PUMP, BYPASS, PULSATILE, AVCO
    K770821 PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT