Modification to Aquadex Flexflow System
FDA 510(k) K070512 · Chf Solutions, Inc.
510(k) numberK070512
Submission
- Device name
- Modification to Aquadex Flexflow System
- Applicant
- Chf Solutions, Inc.
Brooklyn Park Mn, MN, US - Received
- February 22, 2007
- Decision date
- April 27, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K192756 | Aquadex FlexFlow System 2.0KDI · Traditional | 02/24/2020SE |
| K071854 | Aquadex Flexflow SystemKDI · Special | 09/07/2007SE |
| K062922 | Modification to Aquadex Flexflow SystemKDI · Special | 12/13/2006SE |
| K060008 | Aquadex Flexflow SystemKDI · Special | 02/02/2006SE |
| K050609 | Aquadex SystemKDI · Traditional | 11/09/2005SE |
| K041791 | 5.2F Dual Lumen Extended Length Catheter (Delc)NQJ · Traditional | 09/10/2004SE |
| K040489 | Aquadex System 100, Model A1100KDI · Special | 04/27/2004SE |
| K031689 | Dual Lumen Extended Length Catheter (Delc)NQJ · Traditional | 12/23/2003SE |
| K023874 | System 100 Ultrafiltration CatheterKDI · Traditional | 11/20/2003SE |
| K024124 | System 100-UF 500 Circuit with In-Line Needleless Access PortKDI · Traditional | 03/14/2003SE |
Questions and answers
When was Modification to Aquadex Flexflow System cleared by the FDA?
Modification to Aquadex Flexflow System (K070512) received a 510(k) decision of Substantially Equivalent on April 27, 2007, 64 days after the submission was received.
What is the product code of K070512?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.