K234060
- 510(k) number
- K234060
- Device name
- KIDNEYvault Portable Renal Perfusion System
- Applicant
- Paragonix Technologies MA · US
- Product code
- KDN — System, Perfusion, Kidney
- Decision date
- 2024-10-23
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K234060.pdf
Official FDA record: K234060
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.