510(k) Report

Devices descending from K013733

14 later devices reach System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0417915.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc.20042—
+1K040489Aquadex System 100, Model A1100Chf Solutions, Inc.20046—
+1K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc.20033—
+1K023874System 100 Ultrafiltration CatheterChf Solutions, Inc.20030—
+1K024124System 100-UF 500 Circuit with in-Line Needleless Access PortChf Solutions, Inc.20031—
+1K023224Infusion Catheter Extension SetChf Solutions, Inc.20021—
+2K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Nuwellis, Inc.20231—
+2K050609Aquadex SystemChf Solutions, Inc.20055—
+3K252226Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended…Nuwellis, Inc.20250—
+3K060008Aquadex Flexflow SystemChf Solutions, Inc.20064—
+4K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc.20063—
+5K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc.20072—
+6K071854Aquadex Flexflow SystemChf Solutions, Inc.20071—
+7K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc.20200Class I