Product code QQI

Device name

Interventional Cardiovascular Implant Simulation Software Device

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1405

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset