About This 510(k) Submission
K062798 is an FDA 510(k) clearance for the SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB, 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 February 6, 2008, 505 days after receiving the submission on September 19, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.