# K233515: Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

- Pathway: 510(k) (Traditional)
- Applicant: Nuwellis, Inc.
- Decided: Dec 26, 2023 after 55 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: 4 generations back to K861479 (1986). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031689: Dual Lumen Extended Length Catheter (Delc), Chf Solutions, Inc. (2003) Summary page 5.
- K041791: 5.2F Dual Lumen Extended Length Catheter (Delc), Chf Solutions, Inc. (2004) Summary page 5.

## Most influential descendants
- K252226: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (2025), 0 descendants of its own

## 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/K233515
Methodology: https://510kreport.com/methodology