510(k) K203004
K203004 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System". The FDA issued a decision of Substantially Equivalent on December 17, 2020. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Acist Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2020
- Date Received
- October 1, 2020
- Clearance Type
- Special
- 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