HeartFlow, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
HeartFlow Analysis510(k)Jul 18, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 18, 2025
HeartFlow Analysis510(k)Oct 14, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 14, 2022
HeartFlow Analysis510(k)Jan 8, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 8, 2021