FDA 510(k) Application Details - K251383

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K251383
Device Name	Device, Vascular, For Promoting 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	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2025
Decision Date	05/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review