CORDIS OPTA LP PTA BALLOON CATHETER

CORDIS OPTA LP PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K971448) 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 2, 1997. Regulation: 8.