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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software For Visualization Of Vascular Anatomy And Intravascular Devices
510(k) Number K213838
Device Name AneuGuide
Applicant
ArteryFlow Technology Co., Ltd.
459 Qianmo Rd., Suite C1-501, Binjiang District
Hangzhou City,  CN 310051
Applicant Contact Jianping Xiang
Correspondent
ArteryFlow Technology Co., Ltd.
459 Qianmo Rd., Suite C1-501, Binjiang District
Hangzhou City,  CN 310051
Correspondent Contact Jianping Xiang
Regulation Number892.2050
Classification Product Code
PZO  
Date Received12/09/2021
Decision Date 06/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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