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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K252956
Device Name Helo Thrombectomy System
Applicant
Endovascular Engineering, Inc.
3925 Bohannon Dr.
Suite 300
Menlo Park,  CA  94025
Applicant Contact Debra Cogan
Correspondent
Endovascular Engineering, Inc.
3925 Bohannon Dr.
Suite 300
Menlo Park,  CA  94025
Correspondent Contact Debra Cogan
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received09/16/2025
Decision Date 12/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05597891
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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