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.
FDA 510(k) Cleared Adjunctive Predictive Cardiovascular Indicator Devices (Product Code QAQ)
About Product Code QAQ - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QAQ since 2018, with 4 receiving FDA clearance (average review time: 273 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for QAQ submissions have been consistent, averaging 265 days recently vs 276 days historically.
QAQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →