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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 K261800
Device Name Helo Max Thrombectomy System (HEL2090)
Applicant
Endovascular Engineering
3925 Bohannon Dr., Suite 300
Menlo Park,  CA  94025
Applicant Contact Ishita Raje
Correspondent
Endovascular Engineering
3925 Bohannon Dr., Suite 300
Menlo Park,  CA  94025
Correspondent Contact Ishita Raje
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received06/01/2026
Decision Date 09/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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