AneuGuide

Software For Visualization Of Vascular Anatomy And Intravascular Devices

ArteryFlow Technology Co., Ltd.

The following data is part of a premarket notification filed by Arteryflow Technology Co., Ltd. with the FDA for Aneuguide.

Pre-market Notification Details

Device IDK213838
510k NumberK213838
Device Name:AneuGuide
ClassificationSoftware For Visualization Of Vascular Anatomy And Intravascular Devices
Applicant ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District, Hangzhou,  CN 310051
ContactJianping Xiang
CorrespondentJianping Xiang
ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District, Hangzhou City,  CN 310051
Product CodePZO  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-09
Decision Date2022-06-01

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