FDA 510(k) Application Details - K163004

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K163004
Device Name	Wire, Guide, Catheter
Applicant	Ashitaka Factory of Terumo Coporation 150 Maimaigi-cho Fujinomiya Shizuoka 418-0015 JP Other 510(k) Applications for this Company
Contact	Dina Justice 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	10/28/2016
Decision Date	01/30/2017
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