510(k) K002138 ยท FPA Set, Administration, Intravascular
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
| Applicant | Maersk Medical A/S, Sylmar CA, US |
| Decision | Substantially Equivalent, Aug 29, 2000 |
| Received | Jul 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002138
| 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 Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.