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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 K254305
Device Name BAROguard Donor Lung Preservation System
Applicant
Paragonix Technologies, Inc.
950 Winter St.
North
Waltham,  MA  02451
Applicant Contact Julia Bryant
Correspondent
Paragonix Technologies, Inc.
950 Winter St.
North
Waltham,  MA  02451
Correspondent Contact Julia Bryant
Regulation Number876.5880
Classification Product Code
KDN  
Subsequent Product Code
BZD  
Date Received12/31/2025
Decision Date 01/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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