K250345
- 510(k) number
- K250345
- Device name
- Medline Bag Decanter
- Applicant
- Medline Industries, LP IL · US
- Product code
- LHI — Set, I.V. Fluid Transfer
- Decision date
- 2025-10-24
- Date received
- 2025-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250345.pdf
Official FDA record: K250345
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.