Mississauga, CA · 4 510(k) clearances · 1 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology, Urology | 3 | 2026-06-01 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | Class II | Gastroenterology, Urology | 1 | 2026-09-16 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-07-15 | P250025 | TorEx Lung Perfusion System | Original | PHO | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | Unknown |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-16 | K261913 | X°Port Heart Preservation System | MSB | Class II | Gastroenterology, Urology |
| 2026-06-01 | K260456 | VI°Port Liver Preservation System | KDN | Class II | Gastroenterology, Urology |
| 2025-05-01 | K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | KDN | Class II | Gastroenterology, Urology |
| 2024-11-26 | K240650 | LungProtect | KDN | Class II | Gastroenterology, Urology |