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

    UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491

    K Number: K944956 · Decision Jul 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    5
    Review Days
    280

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    Basic Information

    Device Name
    UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
    K Number
    K944956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Heart Valve Div. Medtronic Cardiovascular Surg
    Date Received
    October 7, 1994
    Decision Date
    July 14, 1995
    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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    Other Clearances by The Heart Valve Div. Medtronic Cardiovascular Surg

    K Number Device Name
    K980534 DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
    K960356 POSTERIOR ANNULOPLASTY BAND (MODEL 607)
    K922269 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493
    K914602 DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED