ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER

ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K091527) manufactured by Cook, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 11, 2009. Regulation: 8.