510(k) K234060 ยท KDN System, Perfusion, Kidney
KIDNEYvault Portable Renal Perfusion System
| Applicant | Paragonix Technologies, Waltham MA, US |
| Decision | Substantially Equivalent, Oct 23, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Paragonix Technologies Inc. Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System
REF# PRGNX-8008-001 Open, Classified |
KDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.