FDA 510(k) Application Details - K202366

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K202366
Device Name	Catheter, Continuous Flush
Applicant	Balt USA, LLC 29 Parker Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Corina Pierson 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	08/19/2020
Decision Date	01/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review