FDA.reportPublic FDA data

GORE® VIABAHN® FORTEGRA Venous Stent

Primary DI
00733132663903
Brand
GORE® VIABAHN® FORTEGRA Venous Stent
Company
W. L. Gore & Associates, Inc.
Model
VNS141002A
Catalog number
VNS141002A
Device description
FORTEGRA VENOUS STENT 14mm x 75mm
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTLStent, Vena Cava

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTLStent, Vena Cava

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250017000GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.2025-12-19QTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132663903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132663903007331326639037331326639030733132663903

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-coated central/peripheral venous stentA tubular, mesh structure, consisting of a metal frame coated with a non-bioabsorbable synthetic polymer, designed to be implanted in a central and/or peripheral vein (e.g., inferior vena cava, iliofemoral vein) to improve blood flow in patients with symptomatic venous outflow obstruction; it is not intended for coronary or intracranial venous stenting. It is intended to provide biocompatibility while leaving pores (holes) to allow cross-luminal (lateral) blood flow (i.e., not a stent-graft). It is typically expanded in situ; disposable devices associated with implantation may be included with the stent.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling 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
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
00733132663682GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663699GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663705GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663712GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663729GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663736GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663743GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663750GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663767GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663774GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663781GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663798GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663804GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663811GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663828GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663835GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663842GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663859GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663866GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663873GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663880GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663897GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663910GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663927GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663934GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663941GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663958GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663965GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663972GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08
00733132663989GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08