# K213422: EkoSonic Endovascular Device, EKOS+ Endovascular Device

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Dec 14, 2021 after 55 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K140151 (2014). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191119: EkoSonic Endovascular Device, Btg International, Inc. (2019) Summary page 4.
- K200648: EKOS PE Endovascular Device with Control System 4.0 (CS4.0), Ekos Corporation (2020) Summary page 4.

## Most influential descendants
- K220866: EKOS+ Endovascular Device (2022), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1491-2022: Product may be mislabeled.
- May 25, 2022 · Class II · Z-1492-2022: Product may be mislabeled.

## Indications for use
The EkoSonicm Endovascular System is indicated for the: * Ultrasound facilitated, controlled and selective intravascular infusion ofphysician-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. 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 ofphysician-specified fluids, including thrombolytics, into the pulmonary arteries and/ or peripheral vasculature.

Source page: https://510kreport.com/device/K213422
Methodology: https://510kreport.com/methodology