510(k) K781334 ยท DXT Injector And Syringe, Angiographic
DISPOSABLE SYRINGE FILL TUBE
| Applicant | Mallinckrodt Group, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 17, 1978 |
| Received | Aug 2, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2012 | Mallinckrodt Inc The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches.
The Handi-Fil Disposa Terminated |
DXT | None listed |
| Jan 20, 2012 | Mallinckrodt Inc Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH
The Li Terminated |
IZQ | None listed |
| Jan 19, 2012 | Mallinckrodt Inc Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico.
The Handi-Fil Disposable Syringe Fill Tube is a sterile Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.