POWERFLEX(TM) 5F PTA BALLOON CATHETER

POWERFLEX(TM) 5F PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K946052) 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 March 2, 1995. Regulation: 8.