OMNILINK. 018 BILIARY STENT SYSTEM

OMNILINK. 018 BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K060817) manufactured by Guidant Endovascular Solutions, Inc.. 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, 2006. Regulation: 8.