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

    TEMP. BIPOLAR EPICARDIAL LEAD

    K Number: K831645 · Decision Jul 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    1
    Review Days
    64

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    Basic Information

    Device Name
    TEMP. BIPOLAR EPICARDIAL LEAD
    K Number
    K831645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cordic Corp.
    Date Received
    May 23, 1983
    Decision Date
    July 26, 1983
    Product Code
    LDF
    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
    LDF Electrode, Pacemaker, Temporary

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