510(k) K243392 · FPA Set, Administration, Intravascular
Infusomat® Space Volumetric Infusion Pump Administration Sets
| Applicant | B.Braun Medical, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Jul 24, 2025 |
| Received | Oct 31, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243392
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.