FDA 510(k) Application Details - K212567

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K212567
Device Name	Catheter, Straight
Applicant	Chengdu Daxan Innovative Medical Tech. Co., Ltd Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District Chengdu 611135 CN Other 510(k) Applications for this Company
Contact	Kevin Huang Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2021
Decision Date	12/07/2022
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