MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)

MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) is an FDA 510(k)-cleared medical device (K032768) manufactured by Medtronic Ave, 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 October 8, 2003. Regulation: 8.