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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