# K080392: EndoWave Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Apr 30, 2008 after 77 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: 14 generations back to K904788 (1990). 36 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072507: Endowave Infusion System, Ekos Corp. (2007) Summary page 1.
- K062508: Neurowave Micro-Infusion System, Ekos Corp. (2006) Summary page 1.

## Most influential descendants
- K081467: Ekosonic Endovascular System with Rapid Pulse Modulation (2008), 10 descendants of its own
- K111705: Ekosonic Endovascular System (2011), 9 descendants of its own
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (2019), 8 descendants of its own
- K192864: UNI*FUSE Infusion System with Cooper Wire (2020), 2 descendants of its own
- K241851: Versus™ Catheter  (VS110-8B) (2024), 1 descendant of its own

## Indications for use
The Endo Wave 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/K080392
Methodology: https://510kreport.com/methodology