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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 K252377
Device Name NxStage System One with NxView
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Applicant Contact Caitlin Kalda
Correspondent
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Correspondent Contact Caitlin Kalda
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/30/2025
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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