RX HERCULINK ELITE BILIARY STENT SYSTEM

RX HERCULINK ELITE BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K053454) manufactured by Guidant Corporation. 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 5, 2006. Regulation: 8.