510(k) K984088 ยท DXT Injector And Syringe, Angiographic
OPTISTAR MR INJECTOR SYSTEM
| Applicant | Mallinckrodt Inc., Liebel-Flarsheim Business, Cincinnati OH, US |
| Decision | Substantially Equivalent, Dec 6, 1999 |
| Received | Nov 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 29, 2012 | Mallinckrodt Inc Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case.
Sterile, Terminated |
DXT | None listed |
| Feb 29, 2012 | Mallinckrodt Inc Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case.
Sterile, Terminated |
DXT | None listed |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per cas Terminated |
DXT | None listed |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per cas Terminated |
DXT | None listed |
| Feb 29, 2012 | Mallinckrodt Inc Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per ca Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.