Interventional Cardiovascular Implant Simulation Software Device
QQI is the FDA product code for Interventional Cardiovascular Implant Simulation Software Device, a class II device type, regulated under 21 CFR 870.1405. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QQI
- Device name
- Interventional Cardiovascular Implant Simulation Software Device
- 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 patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.
- Regulation
- 21 CFR 870.1405
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code QQI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code QQI| Applicant | Clearances |
|---|---|
| Feops NV | 2 |
| Dasi Simulations | 1 |
| Feops NV | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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