The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for C2000 Automated Manifold Kit.
| Device ID | K052744 |
| 510k Number | K052744 |
| Device Name: | C2000 AUTOMATED MANIFOLD KIT |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUD DR. SUITE 150 Eden Prairie, MN 55344 |
| Contact | A; Saalabi |
| Correspondent | A; Saalabi ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUD 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 | 2005-09-30 |
| Decision Date | 2005-12-16 |
| Summary: | summary |