About This 510(k) Submission
K023907 is an FDA 510(k) clearance for the CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER, a Dilator, Esophageal (Class II — Special Controls, product code KNQ), submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on December 18, 2002, 23 days after receiving the submission on November 25, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.