Submission Details
| 510(k) Number | K203004 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 01, 2020 |
| Decision Date | December 17, 2020 |
| Days to Decision | 77 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
Dec 2020
Decision
77d
Days
Class 2
Risk
About This 510(k) Submission
K203004 is an FDA 510(k) clearance for the ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 17, 2020, 77 days after receiving the submission on October 1, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.
Device Classification
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1650 |
Manufacturer
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