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Interventional Cardiovascular Implant Simulation Software Device

QQI · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1405

Classification

FDA Product Code
QQI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.1405
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
4
Registered establishments
2

Source

Authoritative
FDA Device Classification database
Machine
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