About This 510(k) Submission
K073093 is an FDA 510(k) clearance for the DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by Spire Biomedical, Inc. (Bedford, US). The FDA issued a Cleared decision on January 22, 2008, 82 days after receiving the submission on November 1, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.