OMNILINK .035 BILIARY STENT SYSTEM

OMNILINK .035 BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K011506) 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 June 14, 2001. Regulation: 8.