FDA 510(k) Application Details - K192442

Device Classification Name	More FDA Info for this Device
510(K) Number	K192442
Device Name	FFRangio
Applicant	CathWorks Ltd 3 Rapaport Street Kfar-Saba 4465141 IL Other 510(k) Applications for this Company
Contact	Asaf Azulay 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	09/06/2019
Decision Date	12/09/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review