ULTRA THIN BALLOON DILATATION CATHETER

ULTRA THIN BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K924320) manufactured by Boston Scientific 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 November 9, 1993. Regulation: 8.