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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 K203219
Device Name Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Kathy Nguyen
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Kathy Nguyen
Regulation Number882.5600
Classification Product Code
Subsequent Product Code
Date Received11/02/2020
Decision Date 12/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No