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

    PUMP, BALLOON MODEL 10

    K Number: K781848 · Decision Jan 23, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    92

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    Basic Information

    Device Name
    PUMP, BALLOON MODEL 10
    K Number
    K781848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Avco Medical Products
    Date Received
    October 23, 1978
    Decision Date
    January 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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