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510(k) Data Aggregation

    K Number
    K202919
    Device Name
    ATS 5000 Automatic Tourniquet Instrument
    Manufacturer
    McEwen and Associates Consulting Ltd.
    Date Cleared
    2021-05-20

    (233 days)

    Product Code
    KCY
    Regulation Number
    878.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    McEwen and Associates Consulting Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATS 5000 Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations.
    Device Description
    The ATS 5000 is a non-sterile dual-port microprocessor controlled pneumatic tourniquet instrument intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The ATS 5000 instrument is used in conjunction with available dual port tourniquet cuffs and hoses distributed/supplied by Zimmer Biomet Inc. A cuff is applied to a patient prior to the beginning of a procedure. Connective tubing is then attached to the cuff and then plugged into the ATS 5000 connector ports. The instrument is controlled via a touchscreen user interface.
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