FDA 510(k) Application Details - K242392

Device Classification Name	More FDA Info for this Device
510(K) Number	K242392
Device Name	PATH BGC
Applicant	Crossroads Neurovascular, Inc. 105 North Pointe Dr, Suite D Lake Forest, CA 92630 US Other 510(k) Applications for this Company
Contact	Ryan Breckenridge 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	08/12/2024
Decision Date	05/09/2025
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