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 K250508
Device Name AK 98 Dialysis Machine (955607)
Applicant
Vantive US Healthcare, LLC
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Applicant Contact Kristen Bozzelli
Correspondent
Vantive US Healthcare, LLC
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Correspondent Contact Kristen Bozzelli
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/21/2025
Decision Date 08/01/2025
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
-
-