CORMATRIX ECM FOR VASCULAR REPAIR

CORMATRIX ECM FOR VASCULAR REPAIR is an FDA 510(k)-cleared medical device (K140789) manufactured by Cormatrix Cardiovascular, 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 14, 2014. Regulation: 8.