SCI MED PERICARDIAL SUBSTITUTE

SCI MED PERICARDIAL SUBSTITUTE is an FDA 510(k)-cleared medical device (K791792) manufactured by Scimed Life Systems, 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 December 6, 1979. Regulation: 8.