FDA 510(k) Application Details - K242608

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K242608
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 US Other 510(k) Applications for this Company
Contact	Lynn Allman 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	09/03/2024
Decision Date	01/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review