MODIFICATION TO ZILVER 635 BILIARY STENT

MODIFICATION TO ZILVER 635 BILIARY STENT is an FDA 510(k)-cleared medical device (K080037) 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 July 31, 2008. Regulation: 8.