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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 K261523
Device Name Vertex™ Thrombectomy System
Applicant
Jupiter Endovascular
155 Jefferson Dr.
Menlo Park,  CA  94025
Applicant Contact Nicole Barber
Correspondent
Jupiter Endovascular
155 Jefferson Dr.
Menlo Park,  CA  94025
Correspondent Contact Nicole Barber
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received05/07/2026
Decision Date 08/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT06576427
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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