FDA 510(k) Application Details - K213838

Device Classification Name	More FDA Info for this Device
510(K) Number	K213838
Device Name	AneuGuide
Applicant	ArteryFlow Technology Co., Ltd. 459 Qianmo Road, Suite C1-501, Binjiang District, Hangzhou 310051 CN Other 510(k) Applications for this Company
Contact	Jianping Xiang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2021
Decision Date	06/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review