510(k) K162812 ยท FPA Set, Administration, Intravascular
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set
| Applicant | Unomedical A/S, Osted, DK |
| Decision | Substantially Equivalent, Nov 1, 2017 |
| Received | Oct 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2024 | Unomedical A/S VariSoft Infusion Set, Single Use. Open, Classified |
FPA | None listed |
| Apr 15, 2024 | Unomedical A/S Neria Soft Infusion Set, Product Code 507302, intravascular administration set Open, Classified |
FPA | None listed |
| Nov 21, 2023 | Unomedical A/S VariSoft infusion set, Model Number 1002827 Open, Classified |
FPA | None listed |
| Nov 21, 2023 | Unomedical A/S VariSoft infusion set, Model Number 1002828 Open, Classified |
FPA | None listed |
| Nov 21, 2023 | Unomedical A/S VariSoft infusion set, Model Number 1002830 Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.