510(k) K143538 ยท DXT Injector And Syringe, Angiographic
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
| Applicant | Bayer Medical Care, Inc., Indianaola PA, US |
| Decision | Substantially Equivalent, Aug 14, 2015 |
| Received | Dec 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143538
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2016 | Bayer Healthcare Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit
Usage:
The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.