FDA 510(k) Application Details - K240746

Device Classification Name	More FDA Info for this Device
510(K) Number	K240746
Device Name	Neurovascular Access System Family
Applicant	Q'Apel Medical, Inc. 4245 Technology Drive Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Jim Talbot 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	03/19/2024
Decision Date	11/20/2024
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