OCCLUDER OCCLUSION BALLOON CATHETER

OCCLUDER OCCLUSION BALLOON CATHETER is an FDA 510(k)-cleared medical device (K133750) 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 January 7, 2014. Regulation: 8.