510(k) K031339 ยท DXT Injector And Syringe, Angiographic
OPTIBOLUS
| Applicant | Mallinckrodt Inc., Liebel-Flarsheim Business, Cincinnati OH, US |
| Decision | Substantially Equivalent, Jul 11, 2003 |
| Received | Apr 28, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031339
| 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.