ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM

ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K033393) manufactured by Guidant Corp.. 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 November 9, 2003. Regulation: 8.