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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 K243577
Device Name Radical the Dude 8F Guide Catheter
Applicant
Maduro Medical, Inc.
1731 Dell Ave.
Campbell,  CA  95008
Applicant Contact Janice Kemp
Correspondent
Maduro Medical, Inc.
1731 Dell Ave.
Campbell,  CA  95008
Correspondent Contact Janice Kemp
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received11/19/2024
Decision Date 01/14/2025
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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