FDA 510(k) Application Details - K141707

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K141707
Device Name	Wire, Guide, Catheter
Applicant	LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. 1531 FELTON ROAD SOUTH EUCLID, OH 44121 US Other 510(k) Applications for this Company
Contact	ARTHUR GODDARD Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/2014
Decision Date	01/21/2015
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