510(k) K082905 ยท DXT Injector And Syringe, Angiographic
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
| Applicant | Medrad, Inc., Indianola PA, US |
| Decision | Substantially Equivalent, Jan 12, 2009 |
| Received | Sep 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2016 | Bayer Healthcare Certegra Workstation used in conjunction with Medrad Stellant CT Injection System
Catalog Number # CWKS DISPLAY
Serial Numbers
The Medrad Stellant CT Injector System is intended for the specific pur Terminated |
DXT | None listed |
| May 28, 2015 | Medrad Inc dba Bayer R&I MEDRAD Stellant CT Injector System with Certegra
Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (C Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.