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VenSure Balloon Dilation System 1

by Fiagon GmbH

VenSure Balloon Dilation System 1 (E 01 3526) is a Class I device made by Fiagon GmbH, listed in FDA GUDID since 10 Nov 2022 (UDI-DI 04260759931246), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260759931246 UDI-DI Date10 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
VenSure Balloon Dilation System
Generic name
Nasal/paranasal balloon catheter, non-tracking
Model / Ref / Catalog
1, E 01 3526
Description
Balloon Dilation system as set including Balloon dilation device with bending tool and Inflation device with tubes,
Primary DI / UDI-DI
04260759931246
FDA product code
LRC, PNZ
GMDN term
Nasal/paranasal balloon catheter, non-tracking
Device class
Class I
Regulation number
874.4420, 874.4180
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nasal/paranasal balloon catheter

Similar devices

Other devices filed under FDA product code LRC (Instrument, Ent Manual Surgical).

Other devices from Fiagon GmbH

See all devices from Fiagon GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)