DEN200030 is an FDA 510(k) submission for the FEops HEARTguide. This device is classified as a Interventional Cardiovascular Implant Simulation Software Device (Class II - Special Controls, product code QQI).
Submitted by Feops NV (Gent-Zwijnaarde, BE). The FDA issued a Not Cleared (DENG) decision on September 8, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1405. An Interventional Cardiovascular Implant Simulation Software Device Is A Prescription Device That Provides A Computer Simulation Of An Interventional Cardiovascular Implant Device Inside A Patients Cardiovascular Anatomy. It Performs Computational Modeling To Predict The Interaction Of The Interventional Cardiovascular Implant Device With The Patient-specific Anatomical Environment..
| 510(k) Number | DEN200030 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 07, 2020 |
| Decision Date | September 08, 2021 |
| Days to Decision | 489 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QQI - Interventional Cardiovascular Implant Simulation Software Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1405 |
| 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 Patients Cardiovascular Anatomy. It Performs Computational Modeling To Predict The Interaction Of The Interventional Cardiovascular Implant Device With The Patient-specific Anatomical Environment. |