NQJ

Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-08-13.

NumberDecision dateApplicantDevice nameSummary
K2522262025-08-13Nuwellis, Inc.Dual Lumen Extended Length Catheter (dELC), 6F, 12cm…PDF
K2335152023-12-26Nuwellis, Inc.Dual Lumen Extended Length Catheter (dELC), 6F, 12 c…PDF

2 summaries are archived here for direct download.

Official FDA classification page: NQJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).