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Interventional Cardiovascular Implant Simulation Software Device

FDA product code QQI · 3 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1405
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-02-25 – 2025-11-25

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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