FEops HEARTguide
Interventional Cardiovascular Implant Simulation Software Device
FEops Nv
The following data is part of a premarket notification filed by Feops Nv with the FDA for Feops Heartguide.
Pre-market Notification Details
| Device ID | K214066 |
| 510k Number | K214066 |
| Device Name: | FEops HEARTguide |
| Classification | Interventional Cardiovascular Implant Simulation Software Device |
| Applicant | FEops Nv Technologiepark 122 Gent-zwijnaarde, BE 9052 |
| Contact | Peter Mortier |
| Correspondent | Niels Festjens OrthoGrow Nv Davincilaan 1 Zaventem, BE 1930 |
| Product Code | QQI |
| CFR Regulation Number | 870.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-02-25 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05430002070056 | K214066 | 000 |
| 05430002070094 | K214066 | 000 |
Trademark Results [FEops HEARTguide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FEOPS HEARTGUIDE 87799014 5631131 Live/Registered |
FEops naamloze vennootschap 2018-02-15 |
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