MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER

MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER is an FDA 510(k)-cleared medical device (K130484) 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 August 8, 2013. Regulation: 8.