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

    TEMPORARY CARDIAC PACING WIRE

    K Number: K980503 · Decision Apr 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    204
    Review Days
    60

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    Basic Information

    Device Name
    TEMPORARY CARDIAC PACING WIRE
    K Number
    K980503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ETHICON, Inc.
    Date Received
    February 9, 1998
    Decision Date
    April 10, 1998
    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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