510(k) K193028 ยท DXT Injector And Syringe, Angiographic
MEDRAD Mark 7 Arterion Injection System
| Applicant | Bayer Medical Care, Inc., Indianaola PA, US |
| Decision | Substantially Equivalent, Dec 5, 2019 |
| Received | Oct 30, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193028
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.