IONESCU-SHILEY LOW POROSITY AORTIC GRAFT

IONESCU-SHILEY LOW POROSITY AORTIC GRAFT is an FDA 510(k)-cleared medical device (K831880) 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 October 18, 1983. Regulation: 8.