NQJ — Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use Class II
FDA product code NQJ covers "Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NQJ
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252226 | nuwellis | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extend | August 13, 2025 |
| K233515 | nuwellis | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Exten | December 26, 2023 |
| K041791 | chf solutions | 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | September 10, 2004 |
| K031689 | chf solutions | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | December 23, 2003 |