510(k) DEN250009 ยท SGY Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
VitaSmart Hypothermic Oxygenated Perfusion System
| Applicant | Bridge TO Life, Ltd., Northbrook IL, US |
| Decision | Unknown, Jan 15, 2026 |
| Received | Mar 31, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250009
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.