510(k) K170431 ยท DXT Injector And Syringe, Angiographic
CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
| Applicant | Coeur, Inc., Lebanon TN, US |
| Decision | Substantially Equivalent, Aug 18, 2017 |
| Received | Feb 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170431
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.