# K172000: ClearLumen II Peripheral Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Walk Vascular, LLC
- Decided: Oct 24, 2017 after 113 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: 5 generations back to K010579 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081573: Medtronic Export AP Catheter, Medtronic Vascular (2008) Summary page 4.

## Indications for use
The ClearLumen II Peripheral Thrombectomy System is intended to: - remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and - subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

Source page: https://510kreport.com/device/K172000
Methodology: https://510kreport.com/methodology