SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER

SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K993303) manufactured by Boston Scientific Corp. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 2000. Regulation: 8.