510(k) K252226
- Device
- Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
- Applicant
- Nuwellis, Inc.
- 510(k) number
- K252226
- Product code
- NQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-13
- Date received
- 2025-07-16
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Neil Ayotte
- Address
- 12988 Valley View Rd. Eden Prairie MN US 55344 55344
FDA Registration Numbers#
- 3007137787
- 2183744
- 3003661577
Source Documents#
Other 510(k) Records For Product Code NQJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K041791 | 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Chf Solutions, Inc. | 2004-09-10 |
| K031689 | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Chf Solutions, Inc. | 2003-12-23 |