BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    TEMPORARY PACEMAKER GROUND WIRE

    K Number: K852119 · Decision Sep 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    8
    Review Days
    123

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    Basic Information

    Device Name
    TEMPORARY PACEMAKER GROUND WIRE
    K Number
    K852119
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Scholten Surgical Instruments, Inc.
    Date Received
    May 15, 1985
    Decision Date
    September 15, 1985
    Product Code
    DTB
    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
    DTB Permanent Pacemaker Electrode

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    Other Clearances by Scholten Surgical Instruments, Inc.

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    K852332 TABLE ACCESSORIES, OPERATING ROOM
    K852120 FORCEPS, BIOPSY(NON RIGID)
    K852330 RETRACTOR, SURGICAL
    K852329 STAND, OPERATING ROOM