510(k) K182273 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, Nov 1, 2018 |
| Received | Aug 22, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182273
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Bayer Medical Care, Inc. MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System;
Catalog number: FLEXS-150-QFT; Open, Classified |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.