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510(k) K183361

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2019
Date Received
December 4, 2018
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)
  • K182324 — EkoSonic Endovascular System (November 26, 2018)
  • K172035 — EKOS ultrasound EVD Device, EVD Control Unit (March 24, 2018)
  • K162771 — EkoSonic Endovascular System with Control Unit 4.0 (February 24, 2017)
  • K140151 — EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT (May 21, 2014)

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  • K231653 — BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (July 3, 2023)
  • K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Re (April 20, 2023)
  • K220866 — EKOS+ Endovascular Device (April 20, 2022)
  • K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular Device (December 14, 2021)
  • K211080 — EkoSonic Endovascular Device (November 19, 2021)
  • K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter ( (June 10, 2021)
  • K202347 — UNIFUSE Infusion System with Cooper Wire (September 15, 2020)