FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
VitaSmart Hypothermic Oxygenated Perfusion System
K Number: DEN250009
·
Decision Jan 15, 2026
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
4
Review Days
290
Basic Information
- Device Name
- VitaSmart Hypothermic Oxygenated Perfusion System
- K Number
- DEN250009
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.5881
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Bridge TO Life, Ltd.
- Date Received
- March 31, 2025
- Decision Date
- January 15, 2026
- Product Code
- SGY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SGY | Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant | FDA class 2 | Gastroenterology, Urology |