VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System— 510(k) K230065

Name: FDA 510(k) clearance K230065
Creator: U.S. Food and Drug Administration
Published: 2023-05-26

Substantially Equivalent

Fiagon 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. Device class: 2.

Clearance details

Applicant: Fiagon GmbH
Product code: Code PNZ
Device class: Class 2
Regulation: 21 CFR 874.4180
Advisory panel: Ear, Nose, Throat
Date received: 2023-01-09
Decision date: 2023-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hennigsdorf, DE

Download summary PDF View on FDA.gov ↗

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