# K201998: JETi AIO Peripheral Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Walk Vascular, LLC
- Decided: Nov 17, 2020 after 120 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: 1 generation back to K183403 (2019). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183403: JETi 88 Peripheral Thrombectomy System, Walk Vascular, LLC (2019) Summary page 4.

## Most influential descendants
- K213565: JETi AIO Peripheral Thrombectomy System (2022), 1 descendant of its own
- K232458: JETi™Hydrodynamic Thrombectomy System (2023), 0 descendants of its own

## Indications for use
The JETi AIO 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/K201998
Methodology: https://510kreport.com/methodology