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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 K163530
Device Name PrisMax Control Unit
Applicant
Baxter Healthcare Corp
7601 Northland Dr. Suite 170
Brooklyn Park Mn,  MN  55428
Applicant Contact Chris Scavotto
Correspondent
Baxter Healthcare Corp
7601 Northland Dr. Suite 170
Brooklyn Park Mn,  MN  55428
Correspondent Contact Chris Scavotto
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/16/2016
Decision Date 05/03/2017
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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