510(k) K252891 ยท DXT Injector And Syringe, Angiographic
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
| Applicant | Bayer Medical Care, Inc., Indianaola PA, US |
| Decision | Substantially Equivalent, Feb 13, 2026 |
| Received | Sep 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252891
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.