CRE BALLOON DILATATION CATHETER

CRE BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K110833) manufactured by Boston Scientific Corporation. 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 April 19, 2011. Regulation: 8.