FDA 510(k) Application Details - K190925

Device Classification Name	More FDA Info for this Device
510(K) Number	K190925
Device Name	HeartFlow FFRct Analysis
Applicant	HeartFlow, Inc. 1400 Seaport Boulevard, Building B Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Windi Hary Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2019
Decision Date	08/15/2019
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