# K211080: EkoSonic Endovascular Device

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Nov 19, 2021 after 221 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: 4 generations back to K140151 (2014). 5 ancestors in all.
2 later devices descend 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.

## Most influential descendants
- K222095: BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (2023), 1 descendant of its own
- K231653: BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (2023), 0 descendants of its own

## Indications for use
The EkoSonic Endovascular System is indicated for the: » Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. » Infusion of solutions into the pulmonary arteries. » Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Source page: https://510kreport.com/device/K211080
Methodology: https://510kreport.com/methodology