FDA Product Code
FDA Product Code QQI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1405
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250635 | FEops HEARTguide Simulation Application | Feops NV | 2025-11-25 | Traditional | PDF ↗ |
| K223809 | PrecisionTAVI (v1.1) | Dasi Simulations | 2023-05-30 | Traditional | PDF ↗ |
| K214066 | FEops HEARTguide | Feops NV | 2022-02-25 | Traditional | PDF ↗ |
| DEN200030 | FEops HEARTguide | Feops NV | 2021-09-08 | Direct | — |
Product code QQI · Class II · Cardiovascular. Data: openFDA.