Dual Lumen Extended Length Catheter (Delc)
FDA 510(k) K031689 · Chf Solutions, Inc.
510(k) numberK031689
Submission
- Device name
- Dual Lumen Extended Length Catheter (Delc)
- Applicant
- Chf Solutions, Inc.
Brooklyn Park, MN, US - Received
- June 2, 2003
- Decision date
- December 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQJ – Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Other 510(k)s with product code NQJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended…NQJ · Special | Nuwellis, Inc. | 08/13/2025SE |
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…NQJ · Traditional | Nuwellis, Inc. | 12/26/2023SE |
| K041791 | 5.2F Dual Lumen Extended Length Catheter (Delc)NQJ · Traditional | Chf Solutions, Inc. | 09/10/2004SE |
More from Chf Solutions, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192756 | Aquadex FlexFlow System 2.0KDI · Traditional | 02/24/2020SE |
| K071854 | Aquadex Flexflow SystemKDI · Special | 09/07/2007SE |
| K070512 | Modification to Aquadex Flexflow SystemKDI · Special | 04/27/2007SE |
| 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 |
| 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 Dual Lumen Extended Length Catheter (Delc) cleared by the FDA?
Dual Lumen Extended Length Catheter (Delc) (K031689) received a 510(k) decision of Substantially Equivalent on December 23, 2003, 204 days after the submission was received.
What is the product code of K031689?
The FDA product code is NQJ – Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use, a Class II (moderate risk) device regulated under 21 CFR 876.5540.