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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Perfusion, Kidney
510(k) Number K243870
Device Name X°Port Lung Preservation System; X°Port Lung Preservation Solution
Applicant
Traferox Technologies, Inc.
3505 Laird Rd. Unit 16
Mississauga,  CA L5L 5Y7
Applicant Contact Anuradha Iyer
Correspondent
Traferox Technologies, Inc.
3505 Laird Rd. Unit 16
Mississauga,  CA L5L 5Y7
Correspondent Contact Anuradha Iyer
Regulation Number876.5880
Classification Product Code
KDN  
Date Received12/17/2024
Decision Date 05/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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