510(k) K160648 · FPA Set, Administration, Intravascular
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
| Applicant | Unomedical A/S, Osted, DK |
| Decision | Substantially Equivalent, Aug 10, 2016 |
| Received | Mar 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T) Open, Classified |
FPA | None listed |
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T) Open, Classified |
FPA | None listed |
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T) Open, Classified |
FPA | None listed |
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T) Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.