Cleared Special

FFRct (K182035) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway.

K182035 · HeartFlow, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
129d
Days
Class 2
Risk

K182035 is an FDA 510(k) clearance for the FFRct. Classified as Coronary Vascular Physiologic Simulation Software (product code PJA), Class II - Special Controls.

Submitted by HeartFlow, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 6, 2018 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1415 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all HeartFlow, Inc. devices

Submission Details

510(k) Number K182035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2018
Decision Date December 06, 2018
Days to Decision 129 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PJA Coronary Vascular Physiologic Simulation Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1415
Definition A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01189331 Completed Interventional

CT Coronary Angiography and Computational Fluid Dynamics

Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics

103
Patients (actual)
1
Site
Diagnostic
Purpose
Single blind
Masking
Condition studied Coronary Artery Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Bon-Kwon Koo, MD, PhD
Sponsor Seoul National University Hospital
Started 2009-10-13 → Primary completion 2020-12-31
Primary outcome
fractional flow reserve
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov