DEN250009
- 510(k) number
- DEN250009
- Device name
- VitaSmart Hypothermic Oxygenated Perfusion System
- Applicant
- Bridge TO Life, Ltd. IL · US
- Product code
- SGY — Hypothermic Machine Perfusion System And Accessories
- Decision date
- 2026-01-15
- Date received
- 2025-03-31
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Gastroenterology, Urology
Official FDA record: DEN250009
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.