510(k) K191658 ยท FPA Set, Administration, Intravascular
IV Sets not made with PVC
| Applicant | B.Braun Medical, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Mar 19, 2020 |
| Received | Jun 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following w Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.