510(k) K190102 · DXT Injector And Syringe, Angiographic
DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System
| Applicant | Osprey Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Oct 17, 2019 |
| Received | Jan 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190102
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.