# K083335: Modified Omniwave Endovascular System

- Pathway: 510(k) (Special)
- Applicant: Omnisonics Medical Technologies
- Decided: Dec 15, 2008 after 33 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: 10 generations back to K904788 (1990). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071762: Omniwave Endovascular System, Omnisonics Medical Technologies (2007) Summary page 5.

## Indications for use
The Modified 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/K083335
Methodology: https://510kreport.com/methodology