MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM

MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM is an FDA 510(k)-cleared medical device (K014184) 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 January 17, 2002. Regulation: 8.