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510(k) K171493

MegaVac Mechanical Thrombectomy System by Capture Vascular, Inc. — Product Code QEX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 10, 2017
Date Received: May 22, 2017
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Coronary Mechanical Thrombectomy With Aspiration
Device Class: Class II
Regulation Number: 870.5150
Review Panel: CV
Submission Type

To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.