510(k) K012056

CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM by Cordis Europa, N.V. — Product Code FGE

K012056 is an FDA 510(k) premarket notification submitted by Cordis Europa, N.V. for the device "CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM". The FDA issued a decision of SESU on August 1, 2001. 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 Europa, N.V. has at least 6 other 510(k) clearances on record.