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

    CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)

    K Number: K973475 · Decision Nov 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    89
    Applicant Total
    468
    Review Days
    69

    Basic Information

    Device Name
    CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
    K Number
    K973475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDTRONIC VASCULAR
    Date Received
    September 12, 1997
    Decision Date
    November 20, 1997
    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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