ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K141322) manufactured by Cook Incorporated. 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 26, 2015. Regulation: 8.