# K023224: Infusion Catheter Extension Set

- Pathway: 510(k) (Special)
- Applicant: Chf Solutions, Inc.
- Decided: Oct 25, 2002 after 28 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- 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 K981681 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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)

## Most influential descendants
- K023874: System 100 Ultrafiltration Catheter (2003), 0 descendants of its own

## Indications for use
For use with System 100. Extension set male connector is specifically designed to secure the extension set to the Statock securement device. Connect luer extension fitting directly to the infusion catheter hub only.

Source page: https://510kreport.com/device/K023224
Methodology: https://510kreport.com/methodology