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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K253589
Device Name Liberant™ RX Aspiration Catheter
Applicant
Medtronic Interventional Vascular, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact Nikita Ciandra Vaz
Correspondent
Medtronic Interventional Vascular, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact Nikita Ciandra Vaz
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received11/17/2025
Decision Date 04/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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