# K060422: Lysus Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Mar 9, 2006 after 20 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K904788 (1990). 24 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052071: Lysus Infusion System, Ekos Corp. (2005) Summary page 5.

## Most influential descendants
- K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (2016), 13 descendants of its own
- K071933: Endowave Infusion System (2007), 12 descendants of its own
- K073166: Endowave Infusion System (2008), 11 descendants of its own
- K163306: Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (2016), 10 descendants of its own
- K081467: Ekosonic Endovascular System with Rapid Pulse Modulation (2008), 10 descendants of its own

## Recalls of this device
- Feb 9, 2007 · Not classified · Z-0577-2007: Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.

## 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/K060422
Methodology: https://510kreport.com/methodology