FDA.reportPublic FDA data

Archimedes Dilation Balloon

Primary DI
00856571007074
Brand
Archimedes Dilation Balloon
Company
BRONCUS MEDICAL INC.
Model
10008
Catalog number
10008
Device description
A sterile single use flexible tube with a balloon at or near the distal tip that is inserted through the bronchoscope or sheath and used to dilate the target lung tissue of the bronchial tree.
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K131234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131234000LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)Broncus Medical, Inc.2013-10-15EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856571007074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856571007074008565710070748565710070740856571007074

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.9Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-428-1600CustomerSupport@Broncus.com

Regulatory Flags#

DUNS number
078684808
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856571007265EasyPath RF Introducer Sheath100112026-04-23
00856571007913BroncTru™ Transbronchial Access ToolAK-82-702025-03-31
00856571007920BroncTru™ Transbronchial Access ToolAK-64-602025-03-31
00856571007937BroncTru™ Transbronchial Access ToolAK-46-552025-03-31
00856571007944BroncTru™ Transbronchial Access ToolAK-91-552025-03-31
00856571007951BroncTru™ Transbronchial Access ToolAK-82-002025-03-31
00856571007968BroncTru™ Transbronchial Access ToolAK-64-002025-03-31
00856571007975BroncTru™ Transbronchial Access ToolAK-46-002025-03-31
00856571007982BroncTru™ Transbronchial Access ToolAK-91-002025-03-31
08565710078012BioStar Transbronchial Aspiration NeedleiS2372024-08-19
08565710078029BioStar Transbronchial Aspiration NeedleiS2272024-08-19
00856571007296Archimedes Access Kit10009-910009-92021-10-04
00856571007241Empower RF Catheter10010100102019-11-01
00856571007036Archimedes System40005400052017-06-27
00856571007104Archimedes Planning System40009400092017-06-27
00856571007128LungPoint Planning System, v3.230009300092017-06-27
00856571007173LungPoint VBN System, V3.230005300052017-06-27
00856571007227Archimedes Access Key10009-110009-12017-12-12
00856571007258Archimedes Access Key, 10-pack10009-210009-22019-02-21
00856571007012FleXNeedle10005-110005-12017-05-12

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Primary DI, Brand, Company table
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04719872715122MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
00856571007265EasyPath RF Introducer SheathBRONCUS MEDICAL INC.EOQ2026-04-23
04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
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10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
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10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
10810068810797Monarch™ Laptop P17/P73 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
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