K052744 is an FDA 510(k) clearance for the C2000 AUTOMATED MANIFOLD KIT. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 16, 2005, 77 days after receiving the submission on September 30, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K052744 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2005 |
| Decision Date | December 16, 2005 |
| Days to Decision | 77 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |