FDA 510(k) Application Details - K233205

Device Classification Name	More FDA Info for this Device
510(K) Number	K233205
Device Name	Distal Access Catheter
Applicant	Shanghai HeartCare Medical Technology Co.,Ltd. 590 Ruiqing Rd, Building 4, Suite 201, East Zhangjiang High-Tech Park Shanghai 201201 CN Other 510(k) Applications for this Company
Contact	Tianrong Hong 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	09/28/2023
Decision Date	12/22/2023
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