Aquadex FlexFlow System 2.0

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 Aquadex Flexflow System 2.0.

Pre-market Notification Details

Device IDK192756
510k NumberK192756
Device Name:Aquadex FlexFlow System 2.0
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant CHF Solutions, Inc. 12988 Valley View Road Eden Prairie,  MN  55344
ContactDawn Li
CorrespondentDawn Li
CHF Solutions, Inc. 12988 Valley View Road Eden Prairie,  MN  55344
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-02-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10853072007128 K192756 000
10853072007111 K192756 000
10853072007104 K192756 000
30853072007306 K192756 000

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