# K072507: Endowave Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Oct 4, 2007 after 28 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K904788 (1990). 25 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060084: Lysus Infusion System, Ekos Corp. (2006) Summary page 5.

## Most influential descendants
- K080392: EndoWave Infusion System (2008), 11 descendants of its own
- K073166: Endowave Infusion System (2008), 11 descendants of its own
- 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

## Recalls of this device
- Apr 1, 2008 · Not classified · Z-1773-2008: Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface Cable (CIC) pod which connects to the Control Unit.
- Mar 10, 2008 · Not classified · Z-1752-2008: Potential for unit to burn patient.
- Feb 20, 2008 · Not classified · Z-1892-2008: Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing. Consequently, drug was delivered outside of the treatment zone.

## Indications for use
The EndoWave® 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/K072507
Methodology: https://510kreport.com/methodology