The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Cvi1 Contrast Delivery System, Acist Cvi Contrast Delivery System.
| Device ID | K203004 |
| 510k Number | K203004 |
| Device Name: | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie, MN 55344 |
| Contact | Jeff Koll |
| Correspondent | Jeff Koll ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie, MN 55344 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2020-12-17 |