FDA 510(k) Application Details - K182149

Device Classification Name	More FDA Info for this Device
510(K) Number	K182149
Device Name	FFRangio System
Applicant	CathWorks Ltd 3 Rapaport Street Kfar-Saba 4465141 IL Other 510(k) Applications for this Company
Contact	Miriam Ivenshitz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2018
Decision Date	12/19/2018
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