Devices · HeartFlow, Inc.

HeartFlow Analysis

HeartFlow, Inc. is listed for HeartFlow Analysis (K213857). The FDA list gives October 14, 2022 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PJA as “Coronary Vascular Physiologic Simulation Software”: A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213857

Official FDA database record

Date of final decision

October 14, 2022

Company on the FDA list

HeartFlow, Inc.

Lead panel

Cardiovascular

Primary product code

PJA

openFDA device name for the code

Coronary Vascular Physiologic Simulation Software

Device class

2

Regulation number

870.1415

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary