510(k) K163054 ยท DXT Injector And Syringe, Angiographic
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
| Applicant | Osprey Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Mar 8, 2017 |
| Received | Nov 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163054
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.