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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K250960
Device Name DUO Microcatheter
Applicant
Rev Neuro, LLC
7060 Koll Center Pkwy.
Suite #300
Pleasonton,  CA  94566
Applicant Contact Shiva Ardakani
Correspondent
Rev Neuro, LLC
7060 Koll Center Pkwy.
Suite #300
Pleasonton,  CA  94566
Correspondent Contact Shiva Ardakani
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Codes
DQO   DQY  
Date Received03/31/2025
Decision Date 09/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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