Search Results

HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological,) minor cuts, and lacerations and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds.

HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

HemaDerm™ containing MPH (Microporous Polysaccharide Hemospheres™ ) is manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells. The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.

This document is a 510(k) Premarket Notification from Medafor, Inc. for their device, HemaDerm™. It details the device's intended use and demonstrates its substantial equivalence to predicate devices, but it does NOT contain an acceptance criteria table or the results of a study designed to prove the device meets said criteria.

Therefore, the requested information cannot be extracted from the provided text.

Ask a specific question about this device