The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Cvi1 Contrast Delivery System, A1000 Syringe Kit, A1000v Syringe Kit, Bt2000 Manifold Kit, Bt2000 Manifold Kit, Angiotoiuch Hand Controller Kit.
| Device ID | K191060 |
| 510k Number | K191060 |
| Device Name: | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 35344 |
| Contact | Matthew D. Stepanek |
| Correspondent | Matthew D. Stepanek ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 35344 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-22 |
| Decision Date | 2019-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841716102166 | K191060 | 000 |
| 40841716102200 | K191060 | 000 |
| 40841716102194 | K191060 | 000 |
| 10841716102209 | K191060 | 000 |
| 10841716102193 | K191060 | 000 |
| 30841716102159 | K191060 | 000 |