Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K170574
Device Name Diacap Pro 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 Received02/27/2017
Decision Date 08/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02964429
Reviewed by Third Party No
Combination Product No
-
-