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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 K143482
Device Name xevonta dialyzer
Applicant
B. Braun Avitum AG
Am Buschberg 1
Melsungen,  DE D-34212
Applicant Contact Giuliana Gavioli
Correspondent
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact Tracy Maddock
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/08/2014
Decision Date 03/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT01111266
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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