About This 510(k) Submission
K040413 is an FDA 510(k) clearance for the CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cordis Europa, N.V. (Warren, US). The FDA issued a Cleared decision on June 21, 2004, 124 days after receiving the submission on February 18, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.