FDA 510(k) Application Details - K183045

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K183045
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	Balt USA, LLC 29 Parker Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Nancy Xu Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	MJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2018
Decision Date	04/30/2019
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