510(k) K243404 · LHI Set, I.V. Fluid Transfer
HyHub and HyHub Duo Vial Access Devices
| Applicant | Takeda Pharmaceuticals, Cambridge MA, US |
| Decision | Substantially Equivalent, Jul 18, 2025 |
| Received | Nov 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243404
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.