• 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 K023874
Device Name SYSTEM 100 ULTRAFILTRATION CATHETER
Applicant
CHF SOLUTIONS, INC.
SUITE 170-7601 NORTHLAND DR.
BROOKLYN PARK,  MN  55428
Applicant Contact AMY PETERSON
Correspondent
CHF SOLUTIONS, INC.
SUITE 170-7601 NORTHLAND DR.
BROOKLYN PARK,  MN  55428
Correspondent Contact AMY PETERSON
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
MPB  
Date Received11/21/2002
Decision Date 11/20/2003
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
-
-