FDA 510(k) Application Details - K150232

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K150232
Device Name	Catheter, Intravascular, Diagnostic
Applicant	ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO FUJINOMIYA, SHIZUOKA 418-0015 JP Other 510(k) Applications for this Company
Contact	Monika McDole-Russell Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2015
Decision Date	10/19/2015
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