510(k) K132928 ยท DXT Injector And Syringe, Angiographic
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
| Applicant | Medrad, Inc. / Bayer Medical Care, Inc., Indianola PA, US |
| Decision | Substantially Equivalent, Jan 23, 2014 |
| Received | Sep 18, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132928
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2021 | Bayer Medical Care, Inc. The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is des Terminated |
DXT | None listed |
| Sep 16, 2015 | Bayer Healthcare Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.