510(k) K021898

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

K021898 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM". The FDA issued a decision of SESU on Aug 14, 2002. 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.