510(k) K011071 ยท FPA Set, Administration, Intravascular
PARADIGM QUICK-SET INFUSION SET
| Applicant | Maersk Medical A/S, Northridge CA, US |
| Decision | Substantially Equivalent, Jun 7, 2001 |
| Received | Apr 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2013 | Medtronic MiniMed Medtronic MiniMed Paradigm Insulin Infusion Sets
The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps. Terminated |
FPA | None listed |
| Jul 16, 2009 | Medtronic MiniMed Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399.
The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or M Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.