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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 K211594
Device Name Trevo Trak 21 Microcatheter
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Shivani H Patel
Correspondent
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Shivani H Patel
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Codes
DQO   DQY  
Date Received05/24/2021
Decision Date 11/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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