FDA product code SIU: Predictive Indicator For Long-Term Cardiovascular Outcomes

SIU is the FDA product code for predictive indicator for long-term cardiovascular outcomes. It is a Class II device, regulated under 21 CFR 870.2215 and reviewed by the Cardiovascular panel. Devices under SIU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts long-term cardiovascular outcomes. The device is intended for adjunctive use with other physical vital sign parameters and patient information for preventive care and is not intended to independently direct patient management. The device is not intended for use in acute care settings or to direct treatment of current disease.

Classification

Recalls for SIU devices

openFDA lists no recalls for product code SIU.

Frequently asked questions

What is FDA product code SIU?

SIU is the FDA product code for predictive indicator for long-term cardiovascular outcomes. It is a Class II device, regulated under 21 CFR 870.2215 and reviewed by the Cardiovascular panel.

What device class is SIU?

Class II, regulation 21 CFR 870.2215. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SIU
• Run a recall and safety report across every SIU manufacturer
• Watch product code SIU for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times