# K111705: Ekosonic Endovascular System

- Pathway: 510(k) (Traditional)
- Applicant: Ekos Corporation
- Decided: Aug 3, 2011 after 47 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K904788 (1990). 48 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081467: Ekosonic Endovascular System with Rapid Pulse Modulation, Ekos Corp. (2008) Summary page 5.

## Most influential descendants
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (2019), 8 descendants of its own
- K192864: UNI*FUSE Infusion System with Cooper Wire (2020), 2 descendants of its own
- K241851: Versus™ Catheter  (VS110-8B) (2024), 1 descendant of its own
- K202347: UNIFUSE Infusion System with Cooper Wire (2020), 1 descendant of its own
- K193071: Bashir Plus Endovascular Catheter (2019), 1 descendant 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.
- Oct 2, 2013 · Class II · Z-0133-2014: The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
- May 24, 2012 · Class II · Z-2023-2012: EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report 

## Indications for use
The EkoSonic Endovascular System is intended for the infusion of solutions into the pulmonary arteries.

Source page: https://510kreport.com/device/K111705
Methodology: https://510kreport.com/methodology