510(k) K041796

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM by Cordis Corporation — Product Code FGE

K041796 is an FDA 510(k) premarket notification submitted by Cordis Corporation for the device "PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM". The FDA issued a decision of SESU on August 3, 2004. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Cordis Corporation has at least 10 other 510(k) clearances on record.