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FDA 510(k)

VI°Port™ Liver Preservation System

K-Number: K260456 · 2026-06-01

ApplicantTraferox Technologies, Inc.
Decision Date2026-06-01
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VI°Port™ Liver Preservation System is the device name listed in this FDA 510(k) record. The listed applicant is Traferox Technologies, Inc.. It received FDA 510(k) clearance on 2026-06-01 under 510(k) number K260456. 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 VI°Port™ Liver Preservation System?

VI°Port™ Liver Preservation System is a medical device that received FDA 510(k) clearance on 2026-06-01. The listed applicant is Traferox Technologies, Inc.. The 510(k) number is K260456.

When did VI°Port™ Liver Preservation System receive FDA 510(k) clearance?

VI°Port™ Liver Preservation System received FDA 510(k) clearance on 2026-06-01, under 510(k) number K260456.

Who is the listed applicant for VI°Port™ Liver Preservation System?

The FDA 510(k) record lists Traferox Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VI°Port™ Liver Preservation System?

The FDA product code for VI°Port™ Liver Preservation System is KDN.

Other records listing Traferox Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P250025Normothermic preservation system for transplantation of initially unacceptable donor lungsK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionK240650LungProtect

Related Devices (Code: KDN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261644Perfadex PlusXvivo Perfusion ABK254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges LopezK243384Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life

Official Source

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

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