# K182324: EkoSonic Endovascular System

- Pathway: 510(k) (Special)
- Applicant: Btg International, Inc.
- Decided: Nov 26, 2018 after 91 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K191119: EkoSonic Endovascular Device (2019), 5 descendants of its own
- K211080: EkoSonic Endovascular Device (2021), 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
- 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/K182324
Methodology: https://510kreport.com/methodology