510(k) K873957 ยท FMI Needle, Hypodermic, Single Lumen
NON-CORING HUBER TYPE NEEDLES
| Applicant | Advantage Medical Systems, Inc., Horsham PA, US |
| Decision | Substantially Equivalent, Oct 23, 1987 |
| Received | Sep 28, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. Terminated |
FMI | None listed |
| May 1, 2012 | Churchill Medical Systems, Inc. Churchill Medical Systems Winged Infusion Set, 22Ga, 1",
Latex-Free Winged Infusion Set
Product Code: MBS-2210
Huber type needle set used for the infusion of medical fluids into implantable ports. Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.