K243384
- 510(k) number
- K243384
- Device name
- Belzer UW® Cold Storage Solution (BTLBUW-001)
- Applicant
- Bridge TO Life IL · US
- Product code
- KDN — System, Perfusion, Kidney
- Decision date
- 2025-03-31
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243384.pdf
Official FDA record: K243384
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.