QQI — Interventional Cardiovascular Implant Simulation Software Device Class II
FDA product code QQI covers "Interventional Cardiovascular Implant Simulation Software Device", a Class II medical device regulated under 21 CFR 870.1405. Submissions are reviewed by the Cardiovascular panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QQI
- Device Class
- Class II
- Regulation Number
- 870.1405
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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 patients cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.