510(k) Report

Devices descending from K040489

6 later devices reach Aquadex System 100, Model A1100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050609Aquadex SystemChf Solutions, Inc.20055—
+2K060008Aquadex Flexflow SystemChf Solutions, Inc.20064—
+3K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc.20063—
+4K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc.20072—
+5K071854Aquadex Flexflow SystemChf Solutions, Inc.20071—
+6K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc.20200Class I