IONESCU-SHILEY AORTIC GRAFT VALVE

IONESCU-SHILEY AORTIC GRAFT VALVE is an FDA 510(k)-cleared medical device (K803000) 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 February 1, 1981. Regulation: 8.