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510(k) K200648

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) by Ekos Corporation — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2020
Date Received
March 12, 2020
Clearance Type
Special
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 Ekos Corporation

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