BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CARDIAC COOLING JACKET

    K Number: K851077 · Decision Jul 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    115

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    Basic Information

    Device Name
    CARDIAC COOLING JACKET
    K Number
    K851077
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pat O. Daily
    Date Received
    March 18, 1985
    Decision Date
    July 11, 1985
    Product Code
    KRI
    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
    KRI Accessory Equipment, Cardiopulmonary Bypass

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