# K183361: EkoSonic Endovascular Device with Control Unit 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Btg International, Inc.
- Decided: Apr 5, 2019 after 122 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: 2 generations back to K140151 (2014). 2 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K162771: EkoSonic Endovascular System with Control Unit 4.0, Btg International, Inc. (2017) Summary page 5.

## Most influential descendants
- 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
- K213422: EkoSonic Endovascular Device, EKOS+ Endovascular Device (2021), 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.
- Nov 3, 2020 · Class II · Z-0637-2021: This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EK

## Indications for use
The EkoSonic Endovascular Device with Control Unit 4.0 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/K183361
Methodology: https://510kreport.com/methodology