Waltham, MA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology, Urology | 4 | 2026-01-30 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-30 | K254305 | BAROguard Donor Lung Preservation System | KDN | Class II | Gastroenterology, Urology |
| 2024-10-23 | K234060 | KIDNEYvault Portable Renal Perfusion System | KDN | Class II | Gastroenterology, Urology |
| 2023-08-15 | K223874 | BAROguard | KDN | Class II | Gastroenterology, Urology |
| 2020-07-02 | K201048 | SherpaPak Pediatric Liver Transport System | KDN | Class II | Gastroenterology, Urology |