510(k) K023183 ยท DXT Injector And Syringe, Angiographic
MEDRAD STELLANT CT INJECTOR SYSTEM
| Applicant | Medrad, Inc., Indianola PA, US |
| Decision | Substantially Equivalent, Jan 10, 2003 |
| Received | Sep 24, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023183
| 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 |
| Nov 2, 2011 | Medrad Inc Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865.
Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into Terminated |
DXT | None listed |
| Jul 9, 2010 | Medrad Inc Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK Terminated |
DXT | None listed |
| Nov 16, 2005 | Medrad Inc Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX Terminated |
DXT | None listed |
| Nov 24, 2004 | Medrad Inc Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK. Terminated |
DXT | None listed |
| Oct 22, 2004 | Medrad Inc Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.