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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K192756
Device Name Aquadex FlexFlow System 2.0
Applicant
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie,  MN  55344
Applicant Contact Dawn Li
Correspondent
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie,  MN  55344
Correspondent Contact Dawn Li
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/30/2019
Decision Date 02/24/2020
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
Recalls CDRH Recalls
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