FDA 510(k) Application Details - K223386

Device Classification Name	Device, Neurovascular Embolization   More FDA Info for this Device
510(K) Number	K223386
Device Name	Device, Neurovascular Embolization
Applicant	Balt USA, LLC 29 Parker Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Kavita Chandrashekar Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	HCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2022
Decision Date	12/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review