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

    MYOCARDIAL INSULATOR

    K Number: K843983 · Decision Dec 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    4
    Review Days
    77

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    Basic Information

    Device Name
    MYOCARDIAL INSULATOR
    K Number
    K843983
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Norton Texas Medical Products
    Date Received
    October 11, 1984
    Decision Date
    December 27, 1984
    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 Norton Texas Medical Products

    K Number Device Name
    K842194 PRESSURE MONITOR
    K842992 GRASSHOPPER - RETRACTOR
    K832517 CUSTOM KWIK SET AND/OR PAK