# K220866: EKOS+ Endovascular Device

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Apr 20, 2022 after 26 days
- Product code: QEY (Mechanical Thrombolysis 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 K140151 (2014). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213422: EkoSonic Endovascular Device, EKOS+ Endovascular Device, Boston Scientific Corporation (2021) Summary page 4.

## Indications for use
The EKOS+ Endovascular System is indicated for the: » Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis. » Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/or peripheral vasculature.

Source page: https://510kreport.com/device/K220866
Methodology: https://510kreport.com/methodology