FDA 510(k) Application Details - K161546

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K161546
Device Name	Catheter, Percutaneous
Applicant	ASHITAKA FACTORY OF TERUMO CORPORATION 150 MAIMAIGI-CHO FUJINOMIYA SHIZUOKA 418-0015 JP Other 510(k) Applications for this Company
Contact	PHEBE VARGHESE Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2016
Decision Date	10/14/2016
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