FDA.reportPublic FDA data

Vensure Inflation Device

Primary DI
EFIAE0135921
Brand
Vensure Inflation Device
Company
Fiagon GmbH
Model
1
Catalog number
E 01 3592
Device description
Inflation device for Vensure Balloon Dilation System
Published
2022-01-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFIAE0135921PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal/paranasal balloon catheterA sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
312623008
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EFIAE0135061VenSure Balloon Sinus Dilation System1E 01 35062021-06-11
EFIAE0135161VenSure Nav Balloon Sinus Dilation System12021-06-11
04260759931246VenSure Balloon Dilation System1E 01 35262022-11-10
04260759931680VenSure 4D Balloon Dilation System1E 01 35662025-09-18
04260759931260VenSure Nav Balloon Dilation System1E 01 35462022-11-10
04260759931253VenSure Light Balloon Dilation System1E 01 35362022-10-14
04260759930003Integrated HeadrestE0119702025-06-25
04260759930133Navigation Unit Cube4DE011106-HD/8E011106-HD/82025-01-16
042607599301574K Navigation Unit Cube4DE011106-4K/8E011106-4K/82025-01-16
04260759930249Navigation SensorA011000A0110002025-01-16
04260759930300FlexPointerE012002E0120022025-01-16
04260759930317FlexPointer 1.5 mmE012004E0120042025-01-16
04260759930324FlexTube 3mmE012104E0121042025-01-16
04260759930331FlexTube 4mmE012106E0121062025-01-16
04260759930348PointerTube KeatE012107E0121072025-01-16
04260759930355PointerTube KennedyE012108E0121082025-01-16
04260759930447Localizer Adhesive Pad C-TypeE012202CE012202C2025-01-16
EFIAE012202C1Localizer Adhesive padC-Type2020-03-27
EFIAE0111060Fiagon Navigation UnitCUBE4D2020-05-12
EFIAE0120021FlexPointer12016-08-05

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