510(k) DEN250009
DEN250009 is an FDA 510(k) premarket notification submitted by Bridge TO Life, Ltd. for the device "VitaSmart Hypothermic Oxygenated Perfusion System". The FDA issued a decision of De Novo Granted on January 15, 2026. The device falls under product code SGY (Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant), a Class II device regulated under 21 CFR 876.5881. Bridge TO Life, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 15, 2026
- Date Received
- March 31, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
- Device Class
- Class II
- Regulation Number
- 876.5881
- Review Panel
- GU
- Submission Type
A hypothermic machine perfusion system and accessories for orthotopic liver transplant is a device that performs oxygenated perfusion of liver grafts at sub-physiological temperatures until it is transplanted into a recipient patient. This generic type of device may also include perfusion sets, oxygenators, and other components of the perfusion circuit.