# K120508: Clearlumen Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Walk Vascular, LLC
- Decided: Nov 7, 2012 after 260 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: 6 generations back to K904788 (1990). 47 ancestors in all.
3 later devices descend 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)
- K050130: Kerberos Proximal Solutions Rispiration System, Kerberos Proximal Solutions, Inc. (2005) Summary page 1.
- K972610: Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C, Possis Medical, Inc. (2000) Summary page 1.
- K081573: Medtronic Export AP Catheter, Medtronic Vascular (2008) Summary page 1.
- K021096: X-Sizer Catheter System, Ev3 Corporation (2004) Summary page 1.

## Most influential descendants
- K140296: Clearlumen Thrombectomy System (2014), 2 descendants of its own
- K161786: ClearLumen II Thrombectomy System (2016), 1 descendant of its own
- K163051: ClearLumen II Peripheral Thrombectomy System (2017), 0 descendants of its own

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

Source page: https://510kreport.com/device/K120508
Methodology: https://510kreport.com/methodology