CORDIS OPTA 5 PTA BALLOON CATHETER

CORDIS OPTA 5 PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K971579) 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 17, 1997. Regulation: 8.