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510(k) Data Aggregation

    K Number
    K131146
    Device Name
    ARTASSIST AND VENASSIST
    Manufacturer
    ACI MEDICAL, LLC
    Date Cleared
    2014-02-10

    (293 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACI MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff
    Device Description
    The ArtAssist device is a pneumatic compression device that applies pressures to the limbs in timed sequences. There is a pump controller that contains a housing, an air pump, an air reservoir, electrical power supply, pressure regulation, timing regulation and safety circuitry. A set of limb cuffs contains air bladders that fill and apply pressure. A tubing set delivers the air from the pump controller to the limb cuffs. The ArtAssist device increases blood flow to the limb. This is achieved by applying rapid compression to the soft tissues of the limb. The ArtAssist device empties the veins and reduces venous pressure. The reduced venous pressure results in an increased driving pressure to greatly improve blood flow.
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