FDA 510(k) Application Details - K172331

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K172331
Device Name	Introducer, Catheter
Applicant	Lepu Medical Technology (Beijing) Co., Ltd. No. 37 Chaoqian Road Beijing 102200 CN Other 510(k) Applications for this Company
Contact	Xiangdan Jin Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2017
Decision Date	03/02/2018
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review