Fiagon GmbH
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories5
Latest Approval2023-11-20
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K230700 | RIWOtrack Navigation System | OLO | 2023-11-20 | View |
| 510(k) | K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System | PNZ | 2023-05-26 | View |
| 510(k) | K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | PGW | 2021-07-19 | View |
| 510(k) | K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | LRC | 2020-08-26 | View |
| 510(k) | K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | PGW | 2020-03-10 | View |
| 510(k) | K163209 | Fiagon Navigation System | HAW | 2017-09-14 | View |
| 510(k) | K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | PGW | 2017-02-16 | View |
| 510(k) | K162176 | Fiagon Navigation System | PGW | 2016-12-01 | View |
| 510(k) | K161940 | Guidewire 0.6 Single Use | PGW | 2016-09-18 | View |
| 510(k) | K151156 | Fiagon Navigation System | HAW | 2016-04-01 | View |
| 510(k) | K160479 | PointerShell Universal, PointerShell LS | PGW | 2016-03-23 | View |
| 510(k) | K160369 | GuideWire | PGW | 2016-03-10 | View |
No matching devices.