510(k) K161471 ยท DXT Injector And Syringe, Angiographic
MR Syringe Dual Pack for Solaris Injectors
| Applicant | Coeur, Inc., Lebanon TN, US |
| Decision | Substantially Equivalent, Oct 6, 2016 |
| Received | May 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161471
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.