K955002 is an FDA 510(k) clearance for the MAHURKAR 8 FR DUAL LEMEN CATHETER, a Catheter, Hemodialysis, Non-implanted (Class II — Special Controls, product code MPB), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on September 13, 1996, 317 days after receiving the submission on November 1, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K955002 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 1995 |
| Decision Date | September 13, 1996 |
| Days to Decision | 317 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 |