The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Angiographic Injection System, Model R2000-cms.
| Device ID | K010390 |
| 510k Number | K010390 |
| Device Name: | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie, MN 55344 |
| Contact | Carl M Beaurline |
| Correspondent | Carl M Beaurline ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUDS DR. SUITE 150 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 | 2001-02-09 |
| Decision Date | 2001-03-09 |