FDA 510(k) Application Details - K190126

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K190126
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Bend It Technologies Ltd 25 Basel Street Petach Tikva 4951038 IL Other 510(k) Applications for this Company
Contact	Nitza Shoham 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	01/28/2019
Decision Date	08/22/2019
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