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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 K261889
Device Name Trevo Trak 21 Microcatheter
Applicant
Stryker Neurovascular
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact Jesse Nelson
Correspondent
Stryker Neurovascular
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact Jesse Nelson
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQO  
Date Received06/05/2026
Decision Date 07/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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