510(k) K050456 ยท DXT Injector And Syringe, Angiographic
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
| Applicant | Medrad, Inc., Indianola PA, US |
| Decision | Substantially Equivalent, Jun 17, 2005 |
| Received | Feb 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2026 | Bayer Medical Care, Inc. Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System;
Catalog number: AVA 500 MPAT (Part 2 of 2);
Affected material numbers: 87629007 Open, Classified |
DXT | None listed |
| Feb 21, 2013 | Medrad Inc MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to Terminated |
DXT | None listed |
| Jul 22, 2011 | Medrad Inc MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL
Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions Terminated |
DXT | None listed |
| Mar 23, 2010 | Medrad Inc Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231. Terminated |
DXT | None listed |
| Oct 21, 2005 | Medrad Inc Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT Terminated |
LHI | None listed |
| Oct 21, 2005 | Medrad Inc Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT Terminated |
LHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.