510(k) · Cardiovascular

FFRct

by HeartFlow, Inc

FFRct is an AI-enabled medical device from HeartFlow, Inc that the U.S. FDA cleared through 510(k) K182035 on December 6, 2018. Its lead review panel is Cardiovascular and its primary product code is PJA (Coronary Vascular Physiologic Simulation Software).

See also FDA-cleared AI cardiovascular devices in 2018, all FDA AI clearances in 2018, top cardiovascular AI devices.

Key facts

Submission numberK182035
Pathway510(k)
Date of final decision
Company (FDA list)HeartFlow, Inc
Lead review panelCardiovascular
Primary product codePJA — Coronary Vascular Physiologic Simulation Software
Applicant (openFDA)HeartFlow, Inc.
Applicant locationRedwood City, CA, US
Device classClass 2
Regulation number21 CFR 870.1415
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. FFRct went through this pathway (K182035).

openFDA lists it as a Class 2 device under 21 CFR 870.1415. Class II devices are moderate risk and are subject to general and special controls.

Product code PJA covers 8 devices on the FDA AI list. By decision date, this device is #3 of 8 under that code. HeartFlow, Inc has 7 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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