FDA 510(k) Application Details - K232934

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K232934
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Hangzhou Yangshun Medical Technology Co.,Ltd Room 110,Building 2,No.357 Miaohouwang Road XixingSubdistrict,Binjiang District Hangzhou 310000 CN Other 510(k) Applications for this Company
Contact	Hui Dong Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2023
Decision Date	05/30/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review