NQJ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (K252226) | Nuwellis, Inc. | 2025-08-13 |
| Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (K233515) | Nuwellis, Inc. | 2023-12-26 |
| 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K041791) | Chf Solutions, Inc. | 2004-09-10 |
| DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K031689) | Chf Solutions, Inc. | 2003-12-23 |
Track NQJ automatically
Every clearance here is in the API, with alerts when new ones post.