# K041791: 5.2F Dual Lumen Extended Length Catheter (Delc)

- Pathway: 510(k) (Traditional)
- Applicant: Chf Solutions, Inc.
- Decided: Sep 10, 2004 after 70 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: 3 generations back to K861479 (1986). 7 ancestors in all.
2 later devices descend 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). Our reading of the summary gave K031869, FDA’s number for Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical… (Surgical Instruments Service and Savings, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “CHF Solutions, 6F dELC”.
- K013733: System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set, Chf Solutions, Inc. (2002) Summary page 1.

## Most influential descendants
- K233515: Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (2023), 1 descendant of its own
- 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 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the basilic vein (arm) and antecubital region respectively and specifically for use with the Aquadex TM System 100 when the blood flow rate is set at <20ml/minute. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

Source page: https://510kreport.com/device/K041791
Methodology: https://510kreport.com/methodology