CORDIS OPTA PTA BALLOON CATHETER

CORDIS OPTA PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K962945) 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 October 22, 1996. Regulation: 8.