ANGIOSCULPT PTA SCORING BALLOON CATHETER

ANGIOSCULPT PTA SCORING BALLOON CATHETER is an FDA 510(k)-cleared medical device (K122685) manufactured by Angioscore, 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 January 10, 2013. Regulation: 8.