SHELHIGH PERICARDIAL PATCH

SHELHIGH PERICARDIAL PATCH is an FDA 510(k)-cleared medical device (K964467) manufactured by Shelhigh, 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 September 22, 1997. Regulation: 8.