K063431 is an FDA 510(k) clearance for the 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40. This device is classified as 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 29, 2007, 77 days after receiving the submission on November 13, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K063431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2006 |
| Decision Date | January 29, 2007 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSD — Catheter, Hemodialysis, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |