510(k) K051264 ยท FPA Set, Administration, Intravascular
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
| Applicant | Unomedical A/S, Roskilde, DK |
| Decision | Substantially Equivalent, Sep 1, 2005 |
| Received | May 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051264
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2011 | Medtronic Minimed Medtronic MiniMed paradigm mio Infusion Sets MMT-921
The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.