510(k) K191060
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit by
Acist Medical Systems, Inc.
— Product Code DXT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2019
- Date Received
- April 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type