510(k) K031197

MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM by Cordis Corp. — Product Code FGE

K031197 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM". The FDA issued a decision of SESU on June 16, 2003. 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 Corp. has at least 10 other 510(k) clearances on record.