510(k) K060877

PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX by Cordis Corp. — Product Code FGE

K060877 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX". The FDA issued a decision of SESU on April 27, 2006. 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.