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510(k) K213422

EkoSonic Endovascular Device, EKOS+ Endovascular Device by Boston Scientific Corporation — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2021
Date Received
October 20, 2021
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.

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  • K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Re (April 20, 2023)
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  • 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)
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