• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K071854
Device Name AQUADEX FLEXFLOW SYSTEM
Original Applicant
CHF SOLUTIONS, INC.
7601 northland dr. ste. 170
brooklyn park,  MN  55428
Original Contact chris scavotto
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/05/2007
Decision Date 09/07/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-