Product code NQJ— Gastroenterology, Urology
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
- Classification name
- Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 4
- First cleared
- Most recent
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.”
Market context for product code NQJ
FDA has cleared devices under product code NQJ between 2003 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2023
- 2004
- 2003
Top applicants under product code NQJ
Recent clearances under product code NQJ
- K252226 — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101) +1 more
- K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
- K041791 — 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
- K031689 — DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
Data sourced from openFDA. This site is unofficial and independent of the FDA.