15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40

15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 is an FDA 510(k)-cleared medical device (K063431) manufactured by Spire Biomedical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 2007. Regulation: 8.