CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION

CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION is an FDA 510(k)-cleared medical device (K940868) manufactured by Cordis Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 1994. Regulation: 8.