# K031689: Dual Lumen Extended Length Catheter (Delc)

- Pathway: 510(k) (Traditional)
- Applicant: Chf Solutions, Inc.
- Decided: Dec 23, 2003 after 204 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: 2 generations back to K861479 (1986). 6 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K013733: System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set, Chf Solutions, Inc. (2002)
- K971999: Peripherally Inserted Central, B.Braun Medical, Inc. (1997) Summary page 1.
- K030270: 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc, 5F X 60 CM Single Lumen Silicon, Medcomp (2003) Summary page 1.
- K974236: Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB, Medical Components, Inc. (1999) Summary page 1.

## Most influential descendants
- K041791: 5.2F Dual Lumen Extended Length Catheter (Delc) (2004), 2 descendants of its own
- 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 Dual Lumen ELC catheters are peripheral venous access catheters, inserted preferably in the basilic vein (arm) and antecubital region respectively, and specifically for use with the System 100. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

Source page: https://510kreport.com/device/K031689
Methodology: https://510kreport.com/methodology