SGY — Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant Class II
Classification Details
- Product Code
- SGY
- Device Class
- Class II
- Regulation Number
- 876.5881
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250009 | bridge to life | VitaSmart Hypothermic Oxygenated Perfusion System | January 15, 2026 |