510(k) K033394

CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM by Cordis Corp. — Product Code FGE

K033394 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM". The FDA issued a decision of SESU on December 22, 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.