ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING

ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING is an FDA 510(k)-cleared medical device (K133998) 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 April 17, 2014. Regulation: 8.