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FDA 510(k)

X°Port Lung Preservation System; X°Port Lung Preservation Solution

K-Number: K243870 · 2025-05-01

ApplicantTraferox Technologies, Inc.
Decision Date2025-05-01
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

X°Port Lung Preservation System; X°Port Lung Preservation Solution 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 2025-05-01 under 510(k) number K243870. 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 X°Port Lung Preservation System; X°Port Lung Preservation Solution?

X°Port Lung Preservation System; X°Port Lung Preservation Solution is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Traferox Technologies, Inc.. The 510(k) number is K243870.

When did X°Port Lung Preservation System; X°Port Lung Preservation Solution receive FDA 510(k) clearance?

X°Port Lung Preservation System; X°Port Lung Preservation Solution received FDA 510(k) clearance on 2025-05-01, under 510(k) number K243870.

Who is the listed applicant for X°Port Lung Preservation System; X°Port Lung Preservation Solution?

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 X°Port Lung Preservation System; X°Port Lung Preservation Solution?

The FDA product code for X°Port Lung Preservation System; X°Port Lung Preservation Solution 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 lungsK260456VI°Port™ Liver Preservation SystemK240650LungProtect

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 ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243998DCX 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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