510(k) K063503 ยท IZQ Injector, Contrast Medium, Automatic
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
| Applicant | Mallinckrodt Inc., Liebel-Flarsheim Business, Cincinnati OH, US |
| Decision | Substantially Equivalent, Apr 27, 2007 |
| Received | Nov 20, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2008 | Mallinckrodt Inc The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with comput Terminated |
IZQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.