MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT

MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT is an FDA 510(k)-cleared medical device (K020809) manufactured by Cordis 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 April 11, 2002. Regulation: 8.