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510(k) Data Aggregation

    K Number
    K101355
    Device Name
    AUGEASE VASCULAR AUGMENTATION DEVICE
    Manufacturer
    Date Cleared
    2010-10-26

    (165 days)

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

    AUGDVT LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AugEase™ is a foot actuated augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing. It is indicated as an accessory to an ultrasound imaging machine with or without Doppler which may be used for: - Distal augmentations - Proximal augmentations - Reflux measurements of specific venous valves - Vein Mapping - Locating suitable distal vessel for bypass
    Device Description
    The AugEase™ is a foot actuated augmentation device intended to be used during a vascular ultrasound exam of the extremity. It consists of a foot actuated pneumatic device that is used to rapidly inflate and deflate an air bladder cuff that has been placed around the patient limb at the appropriate location. Quickly inflating and deflating the placed cuff creates a waveform image that is captured by the ultrasound machine and used in the diagnosis of a variety of conditions.
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