GORE® VIABAHN® FORTEGRA Venous Stent

Primary DI
00733132663972
Brand
GORE® VIABAHN® FORTEGRA Venous Stent
Company
W. L. Gore & Associates, Inc.
Model
VNS101502A
Catalog number
VNS101502A
Device description
FORTEGRA VENOUS STENT 10mm x 150mm
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
00733132663972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132663972007331326639727331326639720733132663972

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
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntHPT040015AHPT040015A2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntHPT050005AHPT050005A2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntHPT050015AHPT050015A2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntHPT060015AHPT060015A2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntHPT350005AHPT350005A2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntHPT350015AHPT350015A2017-02-13
00733132607068GORE PROPATEN Vascular GraftIRH060545AIRH060545A2017-02-13
00733132607129GORE PROPATEN Vascular GraftIRH463845AIRH463845A2017-02-13
00733132607143GORE PROPATEN Vascular GraftIRH473845AIRH473845A2017-02-13
00733132653690GORE SYNECOR Preperitoneal BiomaterialGKWR4040GKWR40402022-11-08
00733132653706GORE SYNECOR Preperitoneal BiomaterialGKWR3030GKWR30302022-11-08
00733132653713GORE SYNECOR Preperitoneal BiomaterialGKWR4050GKWR40502022-11-08
00733132653720GORE SYNECOR Preperitoneal BiomaterialGKWR3535GKWR35352022-11-08
00733132653737GORE SYNECOR Preperitoneal BiomaterialGKWR3040GKWR30402022-11-08
00733132653744GORE SYNECOR Preperitoneal BiomaterialGKWC09GKWC092021-10-05
00733132605798GORE PROPATEN Vascular GraftH060010AH060010A2017-02-13
00733132605811GORE PROPATEN Vascular GraftH060040AH060040A2017-02-13
00733132605835GORE PROPATEN Vascular GraftH060060AH060060A2017-02-13
00733132605859GORE PROPATEN Vascular GraftH060080AH060080A2017-02-13
00733132605873GORE PROPATEN Vascular GraftH080040AH080040A2017-02-13

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
00733132663903GORE® 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
00733132663989GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.QTL2026-01-08