# K191119: EkoSonic Endovascular Device

- Pathway: 510(k) (Special)
- Applicant: Btg International, Inc.
- Decided: Aug 23, 2019 after 119 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: 3 generations back to K140151 (2014). 4 ancestors in all.
5 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)
- K182324: EkoSonic Endovascular System, Btg International, Inc. (2018) Summary page 5.
- K183361: EkoSonic Endovascular Device with Control Unit 4.0, Btg International, Inc. (2019) Summary page 5.

## Most influential descendants
- 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
- K220866: EKOS+ Endovascular Device (2022), 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/K191119
Methodology: https://510kreport.com/methodology