K080400 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on May 13, 2008, 90 days after receiving the submission on February 13, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K080400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2008 |
| Decision Date | May 13, 2008 |
| Days to Decision | 90 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 |