FDA 510(k) Application Details - K153443

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K153443
Device Name	Wire, Guide, Catheter
Applicant	ASAHI INTECC CO., LTD. 1703 WAKITA-CHO, MORIYAMA-KU NAGOYA 463-0024 JP Other 510(k) Applications for this Company
Contact	YOSHIHIKO FUKUI 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	11/27/2015
Decision Date	02/25/2016
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