QEK · Class II · 21 CFR 870.1415

FDA Product Code QEK: Angiographic Coronary Vascular Physiologic Simulation Software

An Angiographic Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.

Leading manufacturers include Cathworks, Ltd..

Total

Cleared

114d

Avg days

2018

Since

FDA 510(k) Cleared Angiographic Coronary Vascular Physiologic Simulation Software Devices (Product Code QEK)

2 devices

1–2 of 2

Cardiovascular · 133d

About Product Code QEK - Regulatory Context

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Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Dec 09, 2019

Product Code Info

Code	QEK
Device class	Class II
CFR	21 CFR 870.1415
Panel	Cardiovascular

Verify on FDA.gov

View QEK classification on FDA.gov →