FDA Product Code QAQ: Adjunctive Predictive Cardiovascular Indicator
Under FDA product code QAQ, adjunctive predictive cardiovascular indicator devices are cleared to provide additional risk assessment information alongside standard cardiovascular evaluation.
These diagnostic tools use novel biomarkers, waveform analysis, or other physiological parameters to provide additional prognostic information about cardiovascular risk that supplements but does not replace standard diagnostic methods such as stress testing or echocardiography.
QAQ devices are Class II medical devices, regulated under 21 CFR 870.2210 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Edwards Lifesciences, LLC.
List of Adjunctive Predictive Cardiovascular Indicator devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Adjunctive Predictive Cardiovascular Indicator devices (product code QAQ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →