510(k) K112086 ยท DXT Injector And Syringe, Angiographic
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
| Applicant | Medrad, Inc., Indianola PA, US |
| Decision | Substantially Equivalent, Oct 14, 2011 |
| Received | Jul 21, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112086
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2018 | Bayer Medical Care, Inc. MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Med Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.