Not Cleared Direct

DEN130045 - HEARTFLOW FFRCT (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN130045 · Heartflow · Cardiovascular device
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Nov 2014
Decision
387d
Days
Class 2
Risk

DEN130045 is an FDA 510(k) submission (not cleared) for the HEARTFLOW FFRCT. Classified as Coronary Vascular Physiologic Simulation Software (product code PJA), Class II - Special Controls.

Submitted by Heartflow (Redwood City, US). The FDA issued a Not Cleared (DENG) decision on November 26, 2014 after a review of 387 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1415 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 387 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Heartflow devices

Submission Details

510(k) Number DEN130045 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 04, 2013
Decision Date November 26, 2014
Days to Decision 387 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 125d · This submission: 387d
Pathway characteristics

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.