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510(k) Data Aggregation

    K Number
    K160260
    Device Name
    Tempo Temporary Pacing Lead
    Manufacturer
    BIO TRACE MEDICAL, INC.
    Date Cleared
    2016-10-25

    (267 days)

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

    BIO TRACE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BioTrace Medical Tempo Temporary Pacing Lead is indicated for use in temporary intracardiac pacing for a maximum of seven (7) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.
    Device Description
    The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary transvenous intracardiac pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon, active fixation, bipolar electrodes and a soft tip.
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