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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 K253975
Device Name Radical 6F Access Catheter
Applicant
Maduro Medical, Inc.
983 University Ave.
Bldg. A
Los Gatos,  CA  95032
Applicant Contact Janice Kemp
Correspondent
Maduro Medical, Inc.
983 University Ave.
Bldg. A
Los Gatos,  CA  95032
Correspondent Contact Janice Kemp
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received12/11/2025
Decision Date 04/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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