FDA 510(k) Application Details - K231554

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K231554
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Suzhou Haowei Medical Technology Co., Ltd. Room 304, Building 4, Tianyun Square, No.111 Wusongjiang Avenue, Guoxiang Street, Wuzhong District, Suzhou Suzhou 215124 CN Other 510(k) Applications for this Company
Contact	Jinyan Shi 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	05/30/2023
Decision Date	11/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review