GORE® VIABAHN® FORTEGRA Venous Stent

Primary DI: 00733132663859
Brand: GORE® VIABAHN® FORTEGRA Venous Stent
Company: W. L. Gore & Associates, Inc.
Model: VNS161502A
Catalog number: VNS161502A
Device description: FORTEGRA VENOUS STENT 16mmX 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#

wlgore.com

Product Codes#

Code, Name table
Code	Name
QTL	Stent, Vena Cava

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
QTL	Stent, Vena Cava

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
P250017	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
P250017	000	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	2025-12-19	QTL

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00733132663859	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00733132663859	00733132663859	733132663859	0733132663859

GMDN Terms#

Term, Definition table
Term	Definition
Polymer-coated central/peripheral venous stent	A 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
Type	Low	High	Condition
Handling Environment Temperature	15 Degrees Celsius	30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
800-528-8763	mpdcustomercare@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 DI	Brand	Model	Catalog	Published
00733132606290	GORE PROPATEN Vascular Graft Pediatric Shunt	HPT040015A	HPT040015A	2017-02-13
00733132606313	GORE PROPATEN Vascular Graft Pediatric Shunt	HPT050005A	HPT050005A	2017-02-13
00733132606351	GORE PROPATEN Vascular Graft Pediatric Shunt	HPT050015A	HPT050015A	2017-02-13
00733132606375	GORE PROPATEN Vascular Graft Pediatric Shunt	HPT060015A	HPT060015A	2017-02-13
00733132606399	GORE PROPATEN Vascular Graft Pediatric Shunt	HPT350005A	HPT350005A	2017-02-13
00733132606436	GORE PROPATEN Vascular Graft Pediatric Shunt	HPT350015A	HPT350015A	2017-02-13
00733132607068	GORE PROPATEN Vascular Graft	IRH060545A	IRH060545A	2017-02-13
00733132607129	GORE PROPATEN Vascular Graft	IRH463845A	IRH463845A	2017-02-13
00733132607143	GORE PROPATEN Vascular Graft	IRH473845A	IRH473845A	2017-02-13
00733132653690	GORE SYNECOR Preperitoneal Biomaterial	GKWR4040	GKWR4040	2022-11-08
00733132653706	GORE SYNECOR Preperitoneal Biomaterial	GKWR3030	GKWR3030	2022-11-08
00733132653713	GORE SYNECOR Preperitoneal Biomaterial	GKWR4050	GKWR4050	2022-11-08
00733132653720	GORE SYNECOR Preperitoneal Biomaterial	GKWR3535	GKWR3535	2022-11-08
00733132653737	GORE SYNECOR Preperitoneal Biomaterial	GKWR3040	GKWR3040	2022-11-08
00733132653744	GORE SYNECOR Preperitoneal Biomaterial	GKWC09	GKWC09	2021-10-05
00733132605798	GORE PROPATEN Vascular Graft	H060010A	H060010A	2017-02-13
00733132605811	GORE PROPATEN Vascular Graft	H060040A	H060040A	2017-02-13
00733132605835	GORE PROPATEN Vascular Graft	H060060A	H060060A	2017-02-13
00733132605859	GORE PROPATEN Vascular Graft	H060080A	H060080A	2017-02-13
00733132605873	GORE PROPATEN Vascular Graft	H080040A	H080040A	2017-02-13

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00733132663682	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663699	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663705	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663712	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663729	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663736	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663743	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663750	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663767	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663774	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663781	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663798	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663804	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663811	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663828	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663835	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663842	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663866	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663873	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663880	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663897	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663903	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663910	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663927	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663934	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663941	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663958	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663965	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663972	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08
00733132663989	GORE® VIABAHN® FORTEGRA Venous Stent	W. L. Gore & Associates, Inc.	QTL	2026-01-08

GORE® VIABAHN® FORTEGRA Venous Stent

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Storage And Handling#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#