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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System And Accessories, Isolated Heart, Transport And Preservation
510(k) Number K261913
Device Name X°Port Heart 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
MSB  
Date Received06/08/2026
Decision Date 09/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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