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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 K170826
Device Name Perfadex Plus
Applicant
Xvivo Perfusion AB
Sloane,  SE
Applicant Contact Kathleen Johnson
Correspondent
Medical Device Approvals, Inc.
P.O. Box 421
Fairfield,  IA  52556
Correspondent Contact Kathleen Johnson
Regulation Number876.5880
Classification Product Code
KDN  
Date Received03/20/2017
Decision Date 06/22/2018
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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