FDA 510(k) Applications Submitted by CHF Solutions, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040489 |
02/26/2004 |
AQUADEX SYSTEM 100, MODEL A1100 |
CHF SOLUTIONS, INC. |
| K031689 |
06/02/2003 |
DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) |
CHF SOLUTIONS, INC. |
| K041791 |
07/02/2004 |
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) |
CHF SOLUTIONS, INC. |
| K023224 |
09/27/2002 |
INFUSION CATHETER EXTENSION SET |
CHF SOLUTIONS, INC. |
| K023874 |
11/21/2002 |
SYSTEM 100 ULTRAFILTRATION CATHETER |
CHF SOLUTIONS, INC. |
| K024124 |
12/16/2002 |
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT |
CHF SOLUTIONS, INC. |
| K060008 |
01/03/2006 |
AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
| K070512 |
02/22/2007 |
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
| K050609 |
03/10/2005 |
AQUADEX SYSTEM |
CHF SOLUTIONS, INC. |
| K071854 |
07/05/2007 |
AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
| K062922 |
09/28/2006 |
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
| K192756 |
09/30/2019 |
Aquadex FlexFlow System 2.0 |
CHF Solutions, Inc. |
| K013733 |
11/09/2001 |
SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET |
CHF SOLUTIONS, INC. |
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