LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM

LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K060487) 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 March 22, 2006. Regulation: 8.