REGENSIS PERICARDIAL PATCH

REGENSIS PERICARDIAL PATCH is an FDA 510(k)-cleared medical device (K051405) 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 August 30, 2005. Regulation: 8.