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Chf Solutions, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K192756Aquadex FlexFlow System 2.0February 24, 2020
K071854AQUADEX FLEXFLOW SYSTEMSeptember 7, 2007
K070512MODIFICATION TO AQUADEX FLEXFLOW SYSTEMApril 27, 2007
K062922MODIFICATION TO AQUADEX FLEXFLOW SYSTEMDecember 13, 2006
K060008AQUADEX FLEXFLOW SYSTEMFebruary 2, 2006
K050609AQUADEX SYSTEMNovember 9, 2005
K0417915.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)September 10, 2004
K040489AQUADEX SYSTEM 100, MODEL A1100April 27, 2004
K031689DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)December 23, 2003
K023874SYSTEM 100 ULTRAFILTRATION CATHETERNovember 20, 2003
K024124SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORTMarch 14, 2003
K023224INFUSION CATHETER EXTENSION SETOctober 25, 2002
K013733SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SETJune 3, 2002