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510(k) K253407

NeVa PV Thrombectomy Device by Vesalio, Inc. — Product Code QEX

Clearance Details

Decision: SESU ()
Decision Date: November 24, 2025
Date Received: September 30, 2025
Clearance Type: Traditional
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.