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FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm .

This combination of FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer, a belt and a hemostatic dressing and is called FemoStop®Gold Femoral Compression System. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The pressure of the dome is controlled by the integrated pump and the manometer. The arch and belt provide counter pressure for the dome. The sterile hemostatic dressing is placed on the skin incision site as a bacterial barrier and for topical control of bleeding,

I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a 510(k) summary and FDA clearance letter for a medical device called the FemoStop® Femoral Compression System. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not include details of a study with the specific criteria you've requested.

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