K241239
- 510(k) number
- K241239
- Device name
- OrganProtex HTK Solution
- Applicant
- Bridge TO Life, Ltd. IL · US
- Product code
- KDL — Set, Perfusion, Kidney, Disposable
- Decision date
- 2025-01-24
- Date received
- 2024-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K241239.pdf
Official FDA record: K241239
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.