QQI
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Interventional Cardiovascular Implant Simulation Software Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1405
- Medical specialty
- Cardiovascular
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| FEops HEARTguide Simulation Application (K250635) | Feops NV | 2025-11-25 |
| PrecisionTAVI (v1.1) (K223809) | Dasi Simulations | 2023-05-30 |
| FEops HEARTguide (K214066) | Feops NV | 2022-02-25 |
| FEops HEARTguide (DEN200030) | Feops NV | 2021-09-08 |
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Every clearance here is in the API, with alerts when new ones post.