# K073166: Endowave Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Ekos Corp.
- Decided: Apr 22, 2008 after 165 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K904788 (1990). 45 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071933: Endowave Infusion System, Ekos Corp. (2007) Summary page 1.
- K072507: Endowave Infusion System, Ekos Corp. (2007) Summary page 1.
- K062508: Neurowave Micro-Infusion System, Ekos Corp. (2006) Summary page 1.
- K063620: Ekos Micro-Infusion System, Ekos Corp. (2007) Summary page 1.
- K014054: Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon Material, Edwards Lifesciences, LLC (2002) Summary page 1.
- K003052: Numed Tyshak II and Z-Med II PTV Catheters, NuMED, Inc. (2000) Summary page 1.
- K011557: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters, NuMED, Inc. (2001) Summary page 1.
- K030589: Modification to Numed Tyshak II and Z-Med II PTV Catheters, NuMED, Inc. (2003) 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 EndoWaveTM Infusion System is intended for the infusion of solutions into the pulmonary arteries. The safety and effectiveness of the EKOS EndoWaveTM Infusion system for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.

Source page: https://510kreport.com/device/K073166
Methodology: https://510kreport.com/methodology