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510(k) Data Aggregation

    K Number
    K112384
    Device Name
    ABDOMINAL TOURNIQUET SYSTEM
    Manufacturer
    COMPRESSION WORKS LLC
    Date Cleared
    2011-10-18

    (61 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPRESSION WORKS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Abdominal Aortic Tourniquet is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
    Device Description
    The Abdominal Aortic Tourniquet is a wedge shaped bladder that when inflated pushes in on the lower abdomen compressing all the structures within to include the descending aorta. The Abdominal Aortic Tourniquet (AAT) is designed to be used by military medical personnel in the battlefield to control bleeding in the inguinal area where standard tourniquets cannot be used. The device may be used instead of "mechanical pressure", allowing the medic to attend to other injuries or soldiers. The Abdominal Aortic Tourniquet is used to control a difficult bleed for up to 60 minutes until the injured soldier can be transferred to evacuation personnel for further treatment.
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