MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM

MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K063481) manufactured by Abbott Vascular, 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 September 13, 2007. Regulation: 8.