K101843 is an FDA 510(k) clearance for the DURAMAX CHRONIC 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. (Latham, US). The FDA issued a Cleared decision on October 20, 2010, 111 days after receiving the submission on July 1, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K101843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 01, 2010 |
| Decision Date | October 20, 2010 |
| Days to Decision | 111 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 |