FDA 510(k) Application Details - K250913

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K250913
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Jiangsu Tingsn Technology Co., Ltd. 21st Floor,Building B,No.3-1 Xinjinhu Road, Jiangbei New District Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Jing Wan Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2025
Decision Date	07/19/2025
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