FEops HEARTguide Simulation Application
FDA 510(k) clearance K250635 · decided 2025-11-25
Clearance details
- K-number
- K250635
- Device name
- FEops HEARTguide Simulation Application
- Applicant
- Feops NV
- Decision
- Substantially Equivalent
- Date received
- 2025-03-03
- Decision date
- 2025-11-25
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- QQI
- Device class
- 2
- Regulation number
- 870.1405
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Gent, BE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.