Panels › Cardiovascular › Product code QQI · Class 2
Interventional Cardiovascular Implant Simulation Software Device
Regulation 870.1405
1510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QQI
| Company | 510(k)s | Recalls |
|---|---|---|
| Feops NV | 3 | 0 |
| Dasi Simulations | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 2025 | K250635 | FEops HEARTguide Simulation Application Feops NV, BE | QQI |
| May 30, 2023 | K223809 | PrecisionTAVI (v1.1) Dasi Simulations | QQI |
| Feb 25, 2022 | K214066 | FEops HEARTguide Feops NV, BE | QQI |
| Sep 8, 2021 | DEN200030 | FEops HEARTguide Feops NV, BE | QQI |
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