# K161786: ClearLumen II Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Walk Vascular, LLC
- Decided: Oct 18, 2016 after 111 days
- Product code: QEZ (Aspiration Thrombectomy 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: 8 generations back to K904788 (1990). 49 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140296: Clearlumen Thrombectomy System, Walk Vascular, LLC (2014) Summary page 5.

## Most influential descendants
- K163051: ClearLumen II Peripheral Thrombectomy System (2017), 0 descendants of its own

## Indications for use
The ClearLumen II Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K161786
Methodology: https://510kreport.com/methodology