ZILVER 518 BILIARY STENT

ZILVER 518 BILIARY STENT is an FDA 510(k)-cleared medical device (K033348) manufactured by Cook, 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 December 14, 2003. Regulation: 8.