510(k) K090487 ยท DXT Injector And Syringe, Angiographic
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
| Applicant | Coeur, Inc., Lebanon TN, US |
| Decision | Substantially Equivalent, Oct 19, 2009 |
| Received | Feb 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090487
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.