K243404
- 510(k) number
- K243404
- Device name
- HyHub and HyHub Duo Vial Access Devices
- Applicant
- Takeda Pharmaceuticals MA · US
- Product code
- LHI — Set, I.V. Fluid Transfer
- Decision date
- 2025-07-18
- Date received
- 2024-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243404.pdf
Official FDA record: K243404
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.