BJORK-SHILEY PULMONIC GRAFT VALVE

BJORK-SHILEY PULMONIC GRAFT VALVE is an FDA 510(k)-cleared medical device (K791828) manufactured by Shiley, 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 26, 1979. Regulation: 8.