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510(k) K111705

EKOSONIC ENDOVASCULAR SYSTEM by Ekos Corporation — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2011
Date Received
June 17, 2011
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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