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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 a medical device manufactured by Traferox Technologies, Inc.. It received FDA 510(k) clearance on 2025-05-01 under approval 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. It is manufactured by Traferox Technologies, Inc.. The 510(k) number is K243870.

When was X°Port Lung Preservation System; X°Port Lung Preservation Solution approved by the FDA?

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

What company makes X°Port Lung Preservation System; X°Port Lung Preservation Solution?

X°Port Lung Preservation System; X°Port Lung Preservation Solution is manufactured by Traferox Technologies, Inc..

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.

Related Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT02234128 Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility COMPLETED NCT02161874 Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System COMPLETED NCT04921488 Interest of Artificial Intelligence in Cancer Screening Colonoscopy COMPLETED NCT07224464 The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia. RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Traferox Technologies, Inc.

K240650LungProtect

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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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