FDA 510(k) Application Details - K243175

Device Classification Name	More FDA Info for this Device
510(K) Number	K243175
Device Name	Disposable Intermittent Catheter (TPU Catheter)
Applicant	Chengdu Daxan Innovative Medical Tech. Co., Ltd East Side of Distribution Center 3,No.566,West Section of Kexing Road, Wenjiang District Chengdu 611137 CN Other 510(k) Applications for this Company
Contact	Zeng Wei Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	06/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review