FDA 510(k) Application Details - K230775

Device Classification Name	More FDA Info for this Device
510(K) Number	K230775
Device Name	SOFIA EX Intracranial Support Catheter
Applicant	MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 US Other 510(k) Applications for this Company
Contact	Miranda Beach Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2023
Decision Date	09/14/2023
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