510(k) K173773 ยท DXT Injector And Syringe, Angiographic
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
| Applicant | Bayer Medical Care, Inc., Indianaola PA, US |
| Decision | Substantially Equivalent, Aug 17, 2018 |
| Received | Dec 12, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173773
| 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.