PERIGUARD PERICARDIAL PATCH

PERIGUARD PERICARDIAL PATCH is an FDA 510(k)-cleared medical device (K821532) manufactured by Genetic Laboratories, 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 18, 1982. Regulation: 8.