K965178 is an FDA 510(k) clearance for the NIAGARA DUAL LUMEN CATHETER. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by Vas-Cath, Inc. (Ontario, L5a 3v3, CA). The FDA issued a Cleared decision on August 19, 1997, 238 days after receiving the submission on December 24, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K965178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1996 |
| Decision Date | August 19, 1997 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MPB — Catheter, Hemodialysis, Non-implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |