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

    SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM

    K Number: K853516 · Decision Nov 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    76
    Review Days
    84

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    Basic Information

    Device Name
    SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM
    K Number
    K853516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Sarns
    Date Received
    August 22, 1985
    Decision Date
    November 14, 1985
    Product Code
    DTR
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

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    Other Clearances by 3M Health Care, Sarns

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