K243618
- 510(k) number
- K243618
- Device name
- EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
- Applicant
- Bridge TO Life IL · US
- Product code
- KDN — System, Perfusion, Kidney
- Decision date
- 2025-06-17
- Date received
- 2024-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K243618.pdf
Official FDA record: K243618
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.