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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K262021
Device Name Toro 71 Aspiration Catheter; Toro Aspiration Tubing
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
NRY  
Date Received06/16/2026
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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