GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE

GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE is an FDA 510(k)-cleared medical device (K963368) manufactured by Glycar, 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 October 30, 1997. Regulation: 8.