Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201472
VenSure Balloon Device, VenSure Nav Balloon Device · Fiagon GmbH · decided 2020-08-26 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VenSure Balloon Sinus Dilation System | 1 | Fiagon GmbH | LRC | EFIAE0135061 |
| VenSure Nav Balloon Sinus Dilation System | 1 | Fiagon GmbH | LRC | EFIAE0135161 |