FDA 510(k) Application Details - K231986

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K231986
Device Name	System, X-Ray, Angiographic
Applicant	Synaptive Medical Inc. 555 Richmond St West, Suite 800 Toronto M5V 3B1 CA Other 510(k) Applications for this Company
Contact	Tahmina Afzali Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2023
Decision Date	03/25/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review