EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE

EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE is an FDA 510(k)-cleared medical device (K780762) 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 May 25, 1978. Regulation: 8.