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510(k) Data Aggregation
K Number
K101355Device Name
AUGEASE VASCULAR AUGMENTATION DEVICE
Manufacturer
Date Cleared
2010-10-26
(165 days)
Product Code
Regulation Number
870.5800Why 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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