NQJ
- Product code
- NQJ
- Device name
- Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 4 (all years; only the last 3 years are listed here)
FDA classification definition
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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252226 | 2025-08-13 | Nuwellis, Inc. | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm… | |
| K233515 | 2023-12-26 | Nuwellis, Inc. | Dual Lumen Extended Length Catheter (dELC), 6F, 12 c… |
Official FDA classification page: NQJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).