FDA 510(k) Application Details - K232686

Device Classification Name	More FDA Info for this Device
510(K) Number	K232686
Device Name	CorVista« System
Applicant	CorVista Health, Inc. 7144 13th Place NW, Suite 2200 Washington, DC 20012 US Other 510(k) Applications for this Company
Contact	Gabrielle Zaeska Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2023
Decision Date	09/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review