# K140151: Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit

- Pathway: 510(k) (Traditional)
- Applicant: Btg International, Inc.
- Decided: May 21, 2014 after 119 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162771: EkoSonic Endovascular System with Control Unit 4.0 (2017), 8 descendants of its own
- 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

## Recalls of this device
- Aug 9, 2016 · Class II · Z-2854-2016: The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters,
- Jan 21, 2016 · Class II · Z-0864-2016: The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family
- Jun 24, 2015 · Class II · Z-2148-2015: The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.

## 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.

Source page: https://510kreport.com/device/K140151
Methodology: https://510kreport.com/methodology