FDA 510(k) Application Details - K203625

Device Classification Name	Device, Neurovascular Embolization   More FDA Info for this Device
510(K) Number	K203625
Device Name	Device, Neurovascular Embolization
Applicant	MicroPort NeuroTech (Shanghai) Co., Ltd. 16th Building, 222 Guangdan Road, Pudong New District Shanghai 201318 CN Other 510(k) Applications for this Company
Contact	Qiuhua Zou Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	HCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2020
Decision Date	09/01/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review