CRE BALLOON DILATATION CATHETER

CRE BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K971320) 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 October 8, 1997. Regulation: 8.