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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 K232467
Device Name CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
Applicant
Baxter Healthcare Corporation
25212 W. Illinios Rte. 120
Round Lake,  IL  60073
Applicant Contact Kristen Bozzelli
Correspondent
Baxter Healthcare Corporation
25212 W. Illinios Rte. 120
Round Lake,  IL  60073
Correspondent Contact Kristen Bozzelli
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/15/2023
Decision Date 09/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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