# K243549: JETi Hydrodynamic Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Apr 4, 2025 after 140 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: 14 generations back to K901627 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202218: ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device, Boston Scientific Corporation (2020) Summary page 5.

## Indications for use
The JETiTM Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break- up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

Source page: https://510kreport.com/device/K243549
Methodology: https://510kreport.com/methodology