PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX

About This 510(k) Submission

K060877 is an FDA 510(k) clearance for the PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on April 27, 2006, 27 days after receiving the submission on March 31, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.