# K252226: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

- Pathway: 510(k) (Special)
- Applicant: Nuwellis, Inc.
- Decided: Aug 13, 2025 after 28 days
- Product code: NQJ (Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K861479 (1986). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233515: Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102), Nuwellis, Inc. (2023) Summary page 5.

## Indications for use
The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use.The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

Source page: https://510kreport.com/device/K252226
Methodology: https://510kreport.com/methodology