PhotoFix Decellularized Bovine Pericardium

PhotoFix Decellularized Bovine Pericardium is an FDA 510(k)-cleared medical device (K183635) manufactured by Cryolife, 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 February 13, 2019. Regulation: 8.