FDA.reportPublic FDA data

GORE VIABAHN VBX Balloon Expandable Endo

Primary DI
00733132658268
Brand
GORE VIABAHN VBX Balloon Expandable Endo
Company
W. L. Gore & Associates, Inc.
Model
BXB051502A
Catalog number
BXB051502A
Device description
BX2 HEP REDUCED PROFILE BX2 5MMX15MM 6Fr 135CM Cath
Published
2023-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PRLIliac covered stent, arterial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRLIliac Covered Stent, ArterialUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160021039

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160021039GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESISW. L. Gore & Associates, Inc.2017-01-27PRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132658268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132658268007331326582687331326582680733132658268

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery endovascular stent-graft, drug-coatedA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary and intracranial arteries) to maintain patency and improve luminal diameter, and that includes a heparin coating intended to prevent thrombotic vessel re-narrowing; it may in addition be intended for optional implantation in the common iliac arteries which extends beyond the aortic bifurcation, or for venous implantation. It is comprised of a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft). It is percutaneously inserted to the site of implantation with a disposable delivery device which may be included with the stent-graft.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length1.5Centimeter
Lumen/Inner Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-528-8763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733132666980GORE® TAG® Thoracic Branch EndoprosthesisTAC123110ATAC123110A2026-05-26
00733132666997GORE® TAG® Thoracic Branch EndoprosthesisTAC123410ATAC123410A2026-05-26
00733132667000GORE® TAG® Thoracic Branch EndoprosthesisTAC123710ATAC123710A2026-05-26
00733132667017GORE® TAG® Thoracic Branch EndoprosthesisTAC124010ATAC124010A2026-05-26
00733132667024GORE® TAG® Thoracic Branch EndoprosthesisTAC124510ATAC124510A2026-05-26
00733132607211GORE INTERING Vascular GraftIRST06005005LIRST06005005L2017-02-13
00733132610457GORE-TEX Vascular GraftR20030030R200300302017-01-10
00733132612505GORE-TEX STRETCH Vascular Graft Pediatric ShuntST03005AST03005A2017-01-10
00733132612512GORE-TEX Vascular Graft Pediatric ShuntST03010AST03010A2017-01-10
00733132612536GORE-TEX Vascular Graft Pediatric ShuntST04010AST04010A2017-01-10
00733132612543GORE-TEX Vascular Graft Pediatric ShuntST04015AST04015A2017-01-10
00733132612567GORE-TEX Vascular GraftST05010AST05010A2017-01-10
00733132612574GORE-TEX Vascular GraftST05015AST05015A2017-01-10
00733132612604GORE-TEX Vascular GraftST06015AST06015A2017-01-10
00733132612802GORE-TEX Vascular GraftST35005AST35005A2017-01-10
00733132612819GORE-TEX Vascular GraftST35010AST35010A2017-01-10
00733132612826GORE-TEX Vascular GraftST35015AST35015A2017-01-10
00733132615131GORE VIABAHN Endoprosthesis with HeparinVBH101002VBH1010022015-11-17
00733132615179GORE VIABAHN Endoprosthesis with HeparinVBH111002VBH1110022015-11-17
00733132615858GORE-TEX Vascular Graft Pediatric ShuntVT03010LAVT03010LA2017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00650862428322iCast covered stent system, 8mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
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00650862486322iCast covered stent system, 6mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862487329iCast covered stent system, 7mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862488326iCast covered stent system, 8mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862489323iCast covered stent system, 9mm x 32mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862720594iCast covered stent system, 10mm x 59mm x 120cmAtrium Medical CorporationPRL2026-02-18
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