510(k) K191060 ยท DXT Injector And Syringe, Angiographic
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jul 18, 2019 |
| Received | Apr 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191060
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.