K040301 is an FDA 510(k) clearance for the GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on November 1, 2004, 266 days after receiving the submission on February 9, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K040301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 09, 2004 |
| Decision Date | November 01, 2004 |
| Days to Decision | 266 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 |