FLEXIMA BILIARY CATHETER

FLEXIMA BILIARY CATHETER is an FDA 510(k)-cleared medical device (K023870) manufactured by Boston Scientific/Medi-Tech. 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 December 19, 2002. Regulation: 8.