KIDNEYvault Portable Renal Perfusion System
FDA 510(k) clearance K234060 · decided 2024-10-23
Clearance details
- K-number
- K234060
- Device name
- KIDNEYvault Portable Renal Perfusion System
- Applicant
- Paragonix Technologies
- Decision
- Substantially Equivalent
- Date received
- 2023-12-22
- Decision date
- 2024-10-23
- Days to decision
- 306 days
- Clearance type
- Traditional
- Product code
- KDN
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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| DCX Disposable Cassette (DCX) (K243998) | Institut Geroges Lopez | 2025-04-25 |
| Belzer UW® Cold Storage Solution (BTLBUW-001) (K243384) | Bridge TO Life | 2025-03-31 |
| Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (K243840) | Bridge TO Life | 2025-03-26 |
| LungProtect (K240650) | Traferox Technologies, Inc. | 2024-11-26 |
| Servator P Plus SALF Solution (K230193) | S.A.L.F. Spa | 2023-09-21 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-00 recall (Z-2967-2026) | Paragonix Technologies Inc. | 2026-08-14 |