FFRct

FDA 510(k) K182035 · HeartFlow, Inc.

Substantially Equivalent

510(k) numberK182035

Submission

Device name
FFRct
Applicant
HeartFlow, Inc.
Redwood City, CA, US
Received
July 30, 2018
Decision date
December 6, 2018
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PJA – Coronary Vascular Physiologic Simulation Software
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1415
Specialty
Cardiovascular

A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.

Other 510(k)s with product code PJA

510(k)DeviceApplicantDecision
K250902HeartFlow AnalysisPJA · Traditional HeartFlow, Inc.07/18/2025SE
K213857HeartFlow AnalysisPJA · Traditional HeartFlow, Inc.10/14/2022SE
K213657Deepvessel FFRPJA · Traditional Keyamed Na, Inc.04/01/2022SE
K203329HeartFlow AnalysisPJA · Traditional HeartFlow, Inc.01/08/2021SE
K190925HeartFlow FFRct AnalysisPJA · Traditional HeartFlow, Inc.08/15/2019SE
K161772FFRctPJA · Traditional HeartFlow, Inc.08/24/2016SE
K152733FFRctPJA · Traditional HeartFlow, Inc.01/13/2016SE

More from HeartFlow, Inc.

510(k)DeviceDecision
K250902HeartFlow AnalysisPJA · Traditional 07/18/2025SE
K213857HeartFlow AnalysisPJA · Traditional 10/14/2022SE
K203329HeartFlow AnalysisPJA · Traditional 01/08/2021SE
K190925HeartFlow FFRct AnalysisPJA · Traditional 08/15/2019SE
K161772FFRctPJA · Traditional 08/24/2016SE
K152733FFRctPJA · Traditional 01/13/2016SE

Questions and answers

When was FFRct cleared by the FDA?

FFRct (K182035) received a 510(k) decision of Substantially Equivalent on December 6, 2018, 129 days after the submission was received.

What is the product code of K182035?

The FDA product code is PJA – Coronary Vascular Physiologic Simulation Software, a Class II (moderate risk) device regulated under 21 CFR 870.1415.