# K162771: EkoSonic Endovascular System with Control Unit 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Btg International, Inc.
- Decided: Feb 24, 2017 after 144 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K140151 (2014). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140151: Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit, Btg International, Inc. (2014) Summary page 4.

## Most influential descendants
- K183361: EkoSonic Endovascular Device with Control Unit 4.0 (2019), 7 descendants of its own
- K191119: EkoSonic Endovascular Device (2019), 5 descendants of its own
- K211080: EkoSonic Endovascular Device (2021), 2 descendants of its own
- K200648: EKOS PE Endovascular Device with Control System 4.0 (CS4.0) (2020), 2 descendants of its own
- K222095: BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (2023), 1 descendant of its own

## Recalls of this device
- Oct 13, 2022 · Class II · Z-0149-2023: Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

## 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/K162771
Methodology: https://510kreport.com/methodology