VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System— 510(k) K230065
Substantially EquivalentFiagon GmbH
FDA 510(k) clearance K230065 for VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System, Substantially Equivalent on 2023-05-26. Applicant: Fiagon GmbH.
Clearance details
- Applicant
- Fiagon GmbH
- Product code
- Code PNZ
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hennigsdorf, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.