LIFESTENT TURBO BILIARY STENT SYSTEM

LIFESTENT TURBO BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K061235) manufactured by Edwards Lifesciences, LLC. 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 4, 2006. Regulation: 8.