FDA product code QQI

Interventional Cardiovascular Implant Simulation Software Device

Cardiovascular·Class 2·21 CFR 870.1405
US regulatory classifications
US Product Code (FDA)
QQI
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.1405
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.

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About this record

Interventional Cardiovascular Implant Simulation Software Device is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.