# K052428: Resolution Endovascular System

- Pathway: 510(k) (Traditional)
- Applicant: Omnisonics Medical Technologies
- Decided: Dec 8, 2005 after 97 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: 2 generations back to K970080 (1997). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041705: Resolution Thrombectomy System, Model EV-2, Omnisonics Medical Technologies (2004) Summary page 5.

## Most influential descendants
- K071762: Omniwave Endovascular System (2007), 1 descendant of its own
- K083335: Modified Omniwave Endovascular System (2008), 0 descendants of its own

## Indications for use
The Omnisonics Resolution® Endovascular System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

Source page: https://510kreport.com/device/K052428
Methodology: https://510kreport.com/methodology