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FDA 510(k) Applications Submitted by BTG INTERNATIONAL, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K182324
08/27/2018
EkoSonic Endovascular System
BTG International, Inc.
K183361
12/04/2018
EkoSonic Endovascular Device with Control Unit 4.0
BTG International, Inc.
K172035
07/05/2017
EKOS ultrasound EVD Device, EVD Control Unit
BTG International, Inc.
K162771
10/03/2016
EkoSonic Endovascular System with Control Unit 4.0
BTG International, Inc.
K140151
01/22/2014
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
BTG INTERNATIONAL, INC.
K191119
04/26/2019
EkoSonic Endovascular Device
BTG International, Inc.
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