PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM is an FDA 510(k)-cleared medical device (K041796) manufactured by Cordis Corporation. 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 August 2, 2004. Regulation: 8.