510(k) K203004 ยท DXT Injector And Syringe, Angiographic
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Dec 17, 2020 |
| Received | Oct 1, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203004
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.