510(k) K041545 ยท FPA Set, Administration, Intravascular
CONTACT DETACH
| Applicant | Unomedical A/S, Roskilde, DK |
| Decision | Substantially Equivalent, Jun 30, 2004 |
| Received | Jun 9, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Medtronic MiniMed Inc. Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 6 Terminated |
FPA | None listed |
| Nov 7, 2014 | Unomedical As Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Deta Terminated |
FPA | None listed |
| Nov 7, 2014 | Unomedical As SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; Su Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.