510(k) K000013 ยท DXT Injector And Syringe, Angiographic
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
| Applicant | Acist Medical Systems, Eden Prairie MN, US |
| Decision | Substantially Equivalent, Mar 28, 2000 |
| Received | Jan 3, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000013
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.