510(k) K152218 ยท DXT Injector And Syringe, Angiographic
AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System
| Applicant | Osprey Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 21, 2015 |
| Received | Aug 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152218
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.