FLUORO-TEX CARDIOVASCULAR PATCH

FLUORO-TEX CARDIOVASCULAR PATCH is an FDA 510(k)-cleared medical device (K994032) manufactured by Bridger Biomed, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 2000. Regulation: 8.