510(k) K183267 · DXT Injector And Syringe, Angiographic
DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System
| Applicant | Osprey Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Nov 23, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183267
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.