K952660 is an FDA 510(k) clearance for the BRAUN HEMODIALYSIS CATHETER. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by B.Braun Medical, Inc. (So. San Francisco, US). The FDA issued a Cleared decision on September 17, 1996, 463 days after receiving the submission on June 12, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K952660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1995 |
| Decision Date | September 17, 1996 |
| Days to Decision | 463 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 |