FDA.reportPublic FDA data

GORE TAG Thoracic Branch Endoprosthesis

Primary DI
00733132654345
Brand
GORE TAG Thoracic Branch Endoprosthesis
Company
W. L. Gore & Associates, Inc.
Model
TE4546A
Catalog number
TE4546A
Device description
TAG TBE THORACIC AORTIC EXT 45mmX4.6cm 6.5mm
Published
2022-06-27
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
MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210032000GORE TAG Thoracic Branch Endoprosthesis (TBE Device)W. L. Gore & Associates, Inc.2022-05-13MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132654345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132654345007331326543457331326543450733132654345

GMDN Terms#

Term, Definition table
TermDefinition
Aortic arch endovascular stent-graft extenderA non-bioabsorbable tubular device intended to be implanted within the aortic arch between the left subclavian artery and the left common carotid artery to increase the length of a parent aortic arch endovascular stent-graft during vascular lesion repair. It is typically short in length and made of a metal alloy that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). It is not intended to be implanted in isolation and not intended to cross aortic arch branch vessels. It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge26French
Length4.59Centimeter
Lumen/Inner Diameter45Millimeter

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
00733132666980GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132666997GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667000GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667017GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667024GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00827002603400COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603417COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603424COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603431COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603448COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603455COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603462COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603479COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603407COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603414COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603421COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603438COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603445COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603452COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603469COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603476COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00733132661664GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661671GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661688GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661695GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00827002601598Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601659Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601710Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601741Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601772Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18