510(k) K041791
- Device
- 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
- Applicant
- CHF SOLUTIONS, INC.
- 510(k) number
- K041791
- Product code
- NQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-09-10
- Date received
- 2004-07-02
- Regulation
- 876.5540
- Classification name
- Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- AMY PETERSON
- Address
- 7601 Northland Dr. Suite 170 Brooklyn Park Mn MN US 55428 55428
FDA Registration Numbers#
- 3007137787
- 2183744
- 3003661577
Source Documents#
Other 510(k) Records For Product Code NQJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. | 2025-08-13 |
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. | 2023-12-26 |
| K031689 | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Chf Solutions, Inc. | 2003-12-23 |
Legacy Summary#
summary
FDA Review#
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