510(k) K062798

SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB by Cordis Corp. — Product Code FGE

K062798 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB". The FDA issued a decision of SESU on February 6, 2008. 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.