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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
510(k) Number K210502
Device Name Trevo NXT ProVue Retriever
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Rebecca Rosman
Correspondent
Stryker
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Ashley Twitty
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received02/22/2021
Decision Date 08/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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