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510(k) K162771

EkoSonic Endovascular System with Control Unit 4.0 by Btg International, Inc. — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2017
Date Received
October 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mechanical Thrombolysis Catheter
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To mechanically disrupt thrombus and/or debris in the peripheral vasculature.

Other clearances by Btg International, Inc.

  • K191119 — EkoSonic Endovascular Device (August 23, 2019)
  • K183361 — EkoSonic Endovascular Device with Control Unit 4.0 (April 5, 2019)
  • K182324 — EkoSonic Endovascular System (November 26, 2018)
  • K172035 — EKOS ultrasound EVD Device, EVD Control Unit (March 24, 2018)
  • K140151 — EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT (May 21, 2014)

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  • K220866 — EKOS+ Endovascular Device (April 20, 2022)
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  • K202347 — UNIFUSE Infusion System with Cooper Wire (September 15, 2020)