510(k) K133894 ยท FPA Set, Administration, Intravascular
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Mar 18, 2014 |
| Received | Dec 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133894
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2015 | Terumo Medical Corp Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35. Terminated |
MEG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.