K110936 is an FDA 510(k) clearance for the DURAFLOW 2 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 June 10, 2011, 67 days after receiving the submission on April 4, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K110936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 04, 2011 |
| Decision Date | June 10, 2011 |
| Days to Decision | 67 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 |