KIDNEYvault Portable Renal Perfusion System— 510(k) K234060

Name: FDA 510(k) clearance K234060
Creator: U.S. Food and Drug Administration
Published: 2024-10-23

Substantially Equivalent

Paragonix Technologies

FDA 510(k) clearance K234060 for KIDNEYvault Portable Renal Perfusion System, Substantially Equivalent on 2024-10-23. Applicant: Paragonix Technologies. Device class: 2.

Clearance details

Applicant: Paragonix Technologies
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2023-12-22
Decision date: 2024-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K234060

K-number listed on FDA's recall record

Z-2967-2026 — Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001Class II·Ongoing·Paragonix Technologies Inc.·20260720

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K234060.

Data sourced from openFDA. This site is unofficial and independent of the FDA.