About This 510(k) Submission
K032457 is an FDA 510(k) clearance for the MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on September 4, 2003, 24 days after receiving the submission on August 11, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.