FDA 510(k) Application Details - K173430

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K173430
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Accurate Medical Therapeutics Ltd. 21 Habarzel Street Tel-Aviv 6971029 IL Other 510(k) Applications for this Company
Contact	Eran Miller 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	11/02/2017
Decision Date	01/26/2018
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