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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 K252297
Device Name Toro 88 Superbore Catheter
Applicant
Toro Neurovascular, Inc.
470 Wald
Irvine,  CA  92618
Applicant Contact Ryan Walker
Correspondent
Toro Neurovascular, Inc.
470 Wald
Irvine,  CA  92618
Correspondent Contact Ryan Walker
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received07/23/2025
Decision Date 01/16/2026
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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