FDA 510(k) Applications Submitted by Dirk Mucha
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200041 |
01/08/2020 |
FlexPointer 1.5 Single Use, FlexTube 3 Single Use |
Fiagon GmbH |
| K230065 |
01/09/2023 |
VenSureÖ Balloon Dilation System, VenSureÖ Light Balloon Dilation System, VenSureÖ Nav Balloon Dilation System, VenSureÖ ET Balloon Dilation System |
Fiagon GmbH |
| K160369 |
02/10/2016 |
GuideWire |
FIAGON GMBH |
| K160479 |
02/22/2016 |
PointerShell Universal, PointerShell LS |
FIAGON GMBH |
| K211291 |
04/28/2021 |
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D |
Fiagon GmbH |
| K151156 |
05/01/2015 |
Fiagon Navigation System |
FIAGON GMBH |
| K141456 |
06/02/2014 |
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL |
FIAGON GMBH |
| K201472 |
06/03/2020 |
VenSure Balloon Device, VenSure Nav Balloon Device |
Fiagon GmbH |
| K161940 |
07/14/2016 |
Guidewire 0.6 Single Use |
FIAGON GMBH |
| K162176 |
08/03/2016 |
Fiagon Navigation System |
Fiagon GmbH |
| K163209 |
11/15/2016 |
Fiagon Navigation System |
FIAGON GMBH |
| K133573 |
11/20/2013 |
FIAGON NAVIGATION SYSTEM |
FIAGON GMBH |
| K163416 |
12/05/2016 |
Fiagon Navigation û PointerTube Straight and PointerTube Keat |
FIAGON GMBH |
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