510(k) K042744 ยท DXT Injector And Syringe, Angiographic
OPTIV ANTAGE DH POWER INJECTION SYSTEM
| Applicant | Mallinckrodt Inc., Liebel-Flarsheim Business, Cincinnati OH, US |
| Decision | Substantially Equivalent, Nov 30, 2004 |
| Received | Oct 4, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042744
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2006 | Mallinckrodt Inc OptiVantage DH Power Injection System. Terminated |
CXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.