LIFESTENT FLEXSTART BILIARY STENT SYSTEM

LIFESTENT FLEXSTART BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K053404) 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 December 20, 2005. Regulation: 8.