510(k) DEN250009
- Device
- VitaSmart Hypothermic Oxygenated Perfusion System
- Applicant
- Bridge TO Life, Ltd.
- 510(k) number
- DEN250009
- Product code
- SGY
- Decision
- Unknown (DENG)
- Decision date
- 2026-01-15
- Date received
- 2025-03-31
- Regulation
- 876.5881
- Classification name
- Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Stephen Howerton
- Address
- 707 Skokie Blvd., Suite 340 Northbrook IL US 60062 60062
FDA Registration Numbers#
- 3031884833
- 3012914313
- 3015136750
Source Documents#
510(k) summary PDF not indicated by FDA