MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

Dialyzer, High Permeability With Or Without Sealed Dialysate System

CHF SOLUTIONS, INC.

The following data is part of a premarket notification filed by Chf Solutions, Inc. with the FDA for Modification To Aquadex Flexflow System.

Pre-market Notification Details

Device IDK070512
510k NumberK070512
Device Name:MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant CHF SOLUTIONS, INC. 7601 NORTHLAND DR. STE. 170 Brooklyn Park,  MN  55428
ContactChris Scavotto
CorrespondentChris Scavotto
CHF SOLUTIONS, INC. 7601 NORTHLAND DR. STE. 170 Brooklyn Park,  MN  55428
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-22
Decision Date2007-04-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.