SGY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5881
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VitaSmart Hypothermic Oxygenated Perfusion System (DEN250009) | Bridge TO Life, Ltd. | 2026-01-15 |
Track SGY automatically
Every clearance here is in the API, with alerts when new ones post.