# K041705: Resolution Thrombectomy System, Model EV-2

- Pathway: 510(k) (Traditional)
- Applicant: Omnisonics Medical Technologies
- Decided: Sep 1, 2004 after 70 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: 1 generation back to K970080 (1997). 5 ancestors in all.
3 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)
- K983534: 7F Hydrolyser Thrombectomy Catheter, Cordis Corp. (1999) Summary page 5.
- K990771: 6F Hydrolyser Thrombectomy Catheter, Cordis Corp. (1999) Summary page 5.
- K993816: Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD, Baxter Edwards (2000) Summary page 5.
- K970080: Arrow-Trerotola PTD Catheter, Arrow Intl., Inc. (1997) Summary page 5.
- K990829: Arrow-Trerotola  Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit with Introducer Sheaths),PT-65, Arrow Intl., Inc. (1999) Summary page 5.

## Most influential descendants
- K052428: Resolution Endovascular System (2005), 2 descendants of its own
- 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® Thrombectomy System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

Source page: https://510kreport.com/device/K041705
Methodology: https://510kreport.com/methodology