PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM

PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM is an FDA 510(k)-cleared medical device (K010445) 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 March 15, 2001. Regulation: 8.