510(k) K153141 ยท DXT Injector And Syringe, Angiographic
DyeVert Contrast Modulation System
| Applicant | Osprey Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 4, 2016 |
| Received | Oct 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153141
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.