FDA 510(k) Application Details - K210562

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K210562
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Suzhou Hengrui Hongyuan Medical Co., Ltd. Building B9 Unit 201, No. 218 Xinghu Road, SIP, Suzhou 215123 CN Other 510(k) Applications for this Company
Contact	Qianqian Zhang 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	02/25/2021
Decision Date	10/01/2021
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