FDA 510(k) Application Details - K222679

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K222679
Device Name	Catheter, Continuous Flush
Applicant	VascuPatent Medical (Shenzhen) Co. Ltd. Room 314&316, Building A, Branch 3, Leibai Zhongcheng Life Science Park,No.22 Jinxiu East Road Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Heather Li Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2022
Decision Date	11/07/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review