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510(k) K253730

RoVo Mechanical Thrombectomy System by Verge Medical, Inc. — Product Code QEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2026
Date Received
November 24, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peripheral 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 peripheral vasculature through aspiration.

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