FDA.reportPublic FDA data

GORE VIABAHN VBX Balloon Expandable Endo

Primary DI
00733132637652
Brand
GORE VIABAHN VBX Balloon Expandable Endo
Company
W. L. Gore & Associates, Inc.
Model
BXAL082901A
Catalog number
BXAL082901A
Device description
VIABAHN BX BALLOON EXP ENDO 8mmX29mm 7Fr 80cmCath Heparin
Published
2017-01-31
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
P160021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160021000GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESISW. L. Gore & Associates, Inc.2017-01-27PRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132637652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132637652007331326376527331326376520733132637652

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7French
Device Size Text, specify0
Length29Millimeter
Outer Diameter8Millimeter

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
00650862122916iCast covered stent system, 12mm x 29mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862122923iCast covered stent system, 12mm x 29mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862124118iCast covered stent system, 12mm x 41mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862124125iCast covered stent system, 12mm x 41mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862126112iCast covered stent system, 12mm x 61mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862126129iCast covered stent system, 12mm x 61mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862425321iCast covered stent system, 5mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862426328iCast covered stent system, 6mm x 32mm x 120cm Atrium Medical CorporationPRL2026-02-18
00650862427325iCast covered stent system, 7mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862428322iCast covered stent system, 8mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862429329iCast covered stent system, 9mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862480597iCast covered stent system, 10mm x 59mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862485325iCast covered stent system, 5mm x 32mm x 80cmAtrium Medical CorporationPRL2026-02-18
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
00733132658251GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658268GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658275GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658282GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658299GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658305GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658312GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658329GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658336GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658343GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658350GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658367GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11