FDA 510(k) Application Details - K250133

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K250133
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Nuvascular Inc. 141 Innovation Drive, Suite 100 Irvine, CA 92617 US Other 510(k) Applications for this Company
Contact	Meadow Wang 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	01/17/2025
Decision Date	07/09/2025
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