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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 K260456
Device Name VI°Port™ Liver Preservation System
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 Received02/11/2026
Decision Date 06/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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