510(k) K963071 ยท DXT Injector And Syringe, Angiographic
ANGIOMAT ILLUMENA
| Applicant | Mallinckrodt Inc., Liebel-Flarsheim Business, Cincinnati OH, US |
| Decision | Substantially Equivalent, Sep 23, 1997 |
| Received | Aug 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2011 | Mallinckrodt Inc Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray.
The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw Terminated |
IZQ | None listed |
| Oct 13, 2007 | Mallinckrodt Inc Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO. Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.