# K071762: Omniwave Endovascular System

- Pathway: 510(k) (Traditional)
- Applicant: Omnisonics Medical Technologies
- Decided: Sep 27, 2007 after 90 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: 9 generations back to K904788 (1990). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050147: Trellis-8 Peripheral Infusion System, Bacchus Vascular, Inc. (2005) Summary page 5.
- K050130: Kerberos Proximal Solutions Rispiration System, Kerberos Proximal Solutions, Inc. (2005) Summary page 5.
- K050563: Ekos Peripheral Infusion System, Ekos Corp. (2005) Summary page 5.
- K052428: Resolution Endovascular System, Omnisonics Medical Technologies (2005) Summary page 5.

## Most influential descendants
- K083335: Modified Omniwave Endovascular System (2008), 0 descendants of its own

## Indications for use
The Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.

Source page: https://510kreport.com/device/K071762
Methodology: https://510kreport.com/methodology