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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 K254208
Device Name FLOWRUNNER Aspiration System
Applicant
Expanse Medical, Inc.
7060 Koll Center Pkwy., Suite 300
Pleasanton,  CA  95466
Applicant Contact Shiva Ardakani
Correspondent
Expanse Medical, Inc.
7060 Koll Center Pkwy., Suite 300
Pleasanton,  CA  95466
Correspondent Contact Shiva Ardakani
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received12/29/2025
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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