# K043269: Lysus Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Dec 22, 2004 after 26 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K904788 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042456: Lysus Infusion System, Ekos Corp. (2004) Summary page 5.

## Indications for use
The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Source page: https://510kreport.com/device/K043269
Methodology: https://510kreport.com/methodology