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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 K190779
Device Name Trevo XP ProVue Retriever
Applicant
Stryker
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Rhoda M. Santos
Correspondent
Stryker
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Rhoda M. Santos
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received03/27/2019
Decision Date 06/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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