# K232458: JETi™Hydrodynamic Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Dec 19, 2023 after 126 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: 3 generations back to K183403 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213565: JETi AIO Peripheral Thrombectomy System, Walk Vascular, LLC (2022) Summary page 4.

## Indications for use
The JETi Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

Source page: https://510kreport.com/device/K232458
Methodology: https://510kreport.com/methodology