Devices · CathWorks Ltd

FFRangio System

CathWorks Ltd is listed for FFRangio System (K182149). The FDA list gives December 19, 2018 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 QEK as “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. 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=K182149

Official FDA database record

Date of final decision

December 19, 2018

Company on the FDA list

CathWorks Ltd

Lead panel

Cardiovascular

Primary product code

QEK

openFDA device name for the code

Angiographic 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