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FDA 510(k)

KIDNEYvault Portable Renal Perfusion System

K-Number: K234060 · 2024-10-23

ApplicantParagonix Technologies
Decision Date2024-10-23
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KIDNEYvault Portable Renal Perfusion System is a medical device manufactured by Paragonix Technologies. It received FDA 510(k) clearance on 2024-10-23 under approval number K234060. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIDNEYvault Portable Renal Perfusion System?

KIDNEYvault Portable Renal Perfusion System is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by Paragonix Technologies. The 510(k) number is K234060.

When was KIDNEYvault Portable Renal Perfusion System approved by the FDA?

KIDNEYvault Portable Renal Perfusion System received FDA 510(k) clearance on 2024-10-23, under approval number K234060.

What company makes KIDNEYvault Portable Renal Perfusion System?

KIDNEYvault Portable Renal Perfusion System is manufactured by Paragonix Technologies.

What is the FDA product code for KIDNEYvault Portable Renal Perfusion System?

The FDA product code for KIDNEYvault Portable Renal Perfusion System is KDN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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