De Novo DEN250009
- Device
- VitaSmart Hypothermic Oxygenated Perfusion System
- Contact
- stephen howerton
- De Novo number
- DEN250009
- Product code
- SGY
- Regulation
- 876.5881
- Classification name
- hypothermic machine perfusion system and accessories for orthotopic liver transplant
- Decision
- granted (DENG)
- Decision date
- 2026-01-15
- Date received
- 2025-03-31
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- SGY
- Device name
- Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5881
- Implant
- N
- Life sustain/support
- Y