Product Code: SGY
FDA class 2
21 CFR 876.5881
Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Gastroenterology, Urology
510(k)s
1
FEI Numbers
3
Registration Numbers
3
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SGY
- Device Class
- FDA class 2
- Regulation Number
- 876.5881
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✓
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
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.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | Jan 15, 2026 | Unknown | Bridge TO Life, Ltd. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.