FDA.reportPublic FDA data

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Primary DI
00733132659685
Brand
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Company
W. L. Gore & Associates, Inc.
Model
ATAA43720160A
Catalog number
ATAA43720160A
Device description
EXC TAMBE 37mmX20mmX160mm 22Fr
Published
2024-04-25
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
QZKEndovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZKEndovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic LesionsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230023000GORE EXCLUDER Thoracoabdominal Branch EndoprosthesisW. L. Gore & Associates, Inc.2024-01-12QZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132659685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132659685007331326596857331326596850733132659685

GMDN Terms#

Term, Definition table
TermDefinition
Descending thoracic aorta endovascular stent-graftA non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge22French
Length16Centimeter
Lumen/Inner Diameter20Millimeter
Lumen/Inner Diameter37Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005288763mpdcustomercare@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
00733132659678GORE® EXCLUDER® Thoracoabdominal Branch EndoprosthesisW. L. Gore & Associates, Inc.QZK2024-04-25