FDA 510(k) Application Details - DEN130045

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130045
Device Name	HEARTFLOW FFRCT
Applicant	HEARTFLOW 1400 SEAPORT BLVD BUILDING B REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	Dustin Michaels 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	11/04/2013
Decision Date	11/26/2014
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review