FDA.reportPublic FDA data

Aeris Balloon Dilation Catheter

Primary DI
KG0830
Brand
Aeris Balloon Dilation Catheter
Company
BRYAN MEDICAL, INC.
Model
KG0830
Device description
Aeris Balloon Dilation Catheter 8x30mm
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150951000aeris Balloon Dialation CatheterBryan Medical, Inc.2015-06-25KTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
KG0830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bronchial balloon catheterA sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160067273
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
TG0075Tenax Laser Resistant Endotracheal TubeTG00752020-12-18
KG0530Aeris Balloon Dilation CatheterKG05302020-12-18
KG0630Aeris Balloon Dilation CatheterKG06302020-12-18
KG0730Aeris Balloon Dilation CatheterKG07302020-12-18
KG0930Aeris Balloon Dilation CatheterKG09302020-12-18
KG1030Aeris Balloon Dilation CatheterKG10302020-12-18
KG1240Aeris Balloon Dilation CatheterKG12402020-12-18
KG1640Aeris Balloon Dilation CatheterKG16402020-12-18
KG1840Aeris Balloon Dilation CatheterKG18402020-12-18
TG0055Tenax Laser Resistant Endotracheal TubeTG00552020-12-18
TG0060Tenax Laser Resistant Endotracheal TubeTG00602020-12-18
TG0065Tenax Laser Resistant Endotracheal TubeTG00652020-12-18
TG0070Tenax Laser Resistant Endotracheal TubeTG00702020-12-18
TG0050Tenax Laser Resistant Endotracheal TubeTG00502020-12-17

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Primary DI, Brand, Company table
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