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510(k) Data Aggregation

    K Number
    K023174
    Device Name
    DISPOSABLE TEMPORARY PACING WIRE
    Manufacturer
    RIVER MEDICAL, INC.
    Date Cleared
    2003-06-11

    (261 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    RIVER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery.
    Device Description
    The proposed device and the predicate device(s) are composed of metallic 28- to 32-gauge wire, an extruded insulation coating, a special curved needle to ease the transcutaneous placement of the electrode in the skin, and a snap-off straight needle. The leads are available in various sizes, lengths, and quantities.
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