inforMED
QQIClass II

Interventional Cardiovascular Implant Simulation Software Device

Cardiovascular · 21 CFR 870.1405

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.

MDR events0All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances4All time

Recent MDR events

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No MDR events on file for this product code.

Event type breakdown

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Recalls

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No recalls on file for this product code.

Registered firms

4 firms currently registered for this product code

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