FDA 510(k) Application Details - K232245

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K232245
Device Name	Catheter, Biliary, Diagnostic
Applicant	Jiangsu Vedkang Medical Science and Technology Co., Ltd. No.52, Guoxiang Road, Wujin Economic Development Zone Changzhou 213149 CN Other 510(k) Applications for this Company
Contact	Bao Tian Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2023
Decision Date	02/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review