510(k) K160651 ยท FPA Set, Administration, Intravascular
BD FlowSmart Set, MiniMed Pro-Set
| Applicant | Becton, Dickinson and Company, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Apr 7, 2016 |
| Received | Mar 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2017 | Medtronic Inc. Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) Open, Classified |
FPK | None listed |
| Dec 23, 2016 | Becton Dickinson & Company BD FlowSmart Set MiniMed Pro-set Rx Only
Distributed by Medtronic MiniMed Inc.
8006464633
8185765555
Legal Manufacturer
Becton, Dickinson and Company
USA
BD Medical-Diabetes Care
Becton Dickins Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.