510(k) K912944 ยท DXT Injector And Syringe, Angiographic
CT 8000 DIGITAL INJECTION SYSTEM
| Applicant | Mallinckrodt Group, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Feb 4, 1992 |
| Received | Jul 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912944
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2008 | Mallinckrodt Inc Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging. Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.