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Fiagon GmbH

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories5
Latest FDA decision2026-06-02
TypeNumberDevice NameCodeDateActions
510(k) K261540 Cube 4D Navigation System, VirtuEye ProPGW2026-06-02 View
510(k) K230700 RIWOtrack Navigation SystemOLO2023-11-20 View
510(k) K230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemPNZ2023-05-26 View
510(k) K211291 Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW2021-07-19 View
510(k) K201472 VenSure Balloon Device, VenSure Nav Balloon DeviceLRC2020-08-26 View
510(k) K200041 FlexPointer 1.5 Single Use, FlexTube 3 Single UsePGW2020-03-10 View
510(k) K163209 Fiagon Navigation SystemHAW2017-09-14 View
510(k) K163416 Fiagon Navigation – PointerTube Straight and PointerTube KeatPGW2017-02-16 View
510(k) K162176 Fiagon Navigation SystemPGW2016-12-01 View
510(k) K161940 Guidewire 0.6 Single UsePGW2016-09-18 View
510(k) K151156 Fiagon Navigation SystemHAW2016-04-01 View
510(k) K160479 PointerShell Universal, PointerShell LSPGW2016-03-23 View
510(k) K160369 GuideWirePGW2016-03-10 View
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