About This 510(k) Submission
K990867 is an FDA 510(k) clearance for the RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 2, 1999, 170 days after receiving the submission on March 16, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.