FDA 510(k) Application Details - K200582

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K200582
Device Name	Catheter, Continuous Flush
Applicant	Bend It Technologies Ltd. 25 Basel Street Petach Tikva 4951038 IL Other 510(k) Applications for this Company
Contact	Simona Beilin-Nissan Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2020
Decision Date	06/25/2020
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