OMNILINK .018 BILIARY STENT SYSTEM

OMNILINK .018 BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K033834) manufactured by Guidant 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 January 1, 2004. Regulation: 8.