FDA 510(k) Application Details - K202926

Device Classification Name	More FDA Info for this Device
510(K) Number	K202926
Device Name	Micro Catheter
Applicant	Shanghai Heartcare Medical Technology Co., Ltd. 590 Ruiqing Rd, Building 4, Suite 201, East Zhangjing High-Tech Park Shanghai 201201 CN Other 510(k) Applications for this Company
Contact	Zongyu Xue Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2020
Decision Date	02/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review