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The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or vein after catheterization.

The femoral compression device consists of an arch with a sterile pneumatic pressure dome and a connection tubing and belt. The device is applied on the patient with the dome over the femoral artery or vein and the belt around the patient. A sterile wound dressing is to be placed between the device and the patient making the device a "non-patient contacting device". The user controls the inflation of the dome by increasing or decreasing the pressure with a connected, manual pump (not provided). The dome applies a mechanical pressure over the spot where there is bleeding, while the arch and belt absorb and evenly distribute the opposite force from the dome. Only the femoral compression device is the subject of this submission; the integrated pump with a manometer is not included in the scope of this submission.

The reprocessed femoral compression device is intended for use in the compression of the femoral artery or vein after catheterization.

Reprocessed Femoral Compression Device

The femoral compression system is indicated for the compression of the femoral artery or vein following catheterization.

The femoral compression device is used to provide compression of the femoral artery for hemostasis management after catheterization. The device is comprised of an arch with an attached sterile pneumatic pressure dome, connector tube, stopcock and belt locks. A woven belt is used to secure the device onto the patient. In use, the belt is placed under and around the patient's hips and the arch is placed over the patient's groin with the dome atop the puncture site. The belt is attached to the arch via the adjustable belt locks and is tightened. A pneumatic pump and manometer are attached to the stopcock connector. The user controls the mechanical pressure applied to the puncture site by increasing or decreasing air pressure applied to the dome. The arch and belt absorb and distribute the opposing force from the dome. Vanguard receives previously used compression devices from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.