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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thrombectomy Whole Blood Return System
510(k) Number K253717
Device Name Helo™ Return
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 Number868.5830
Classification Product Code
SHJ  
Date Received11/24/2025
Decision Date 10/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT05597891
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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