K203004 is an FDA 510(k) clearance for the ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System. 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 17, 2020, 77 days after receiving the submission on October 1, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K203004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2020 |
| Decision Date | December 17, 2020 |
| Days to Decision | 77 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |