FDA.reportPublic FDA data

GORE VIATORR TIPS Endoprosthesis

Primary DI
00733132609789
Brand
GORE VIATORR TIPS Endoprosthesis
Company
W. L. Gore & Associates, Inc.
Model
PTB088275
Catalog number
PTB088275
Device description
VIATORR ENDOPROTHESIS 8MMX8/2CM VIATORR
Published
2017-02-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIRShunt, Portosystemic, Endoprosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIRShunt, Portosystemic, EndoprosthesisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040027033

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040027033GORE VIATORR TIPSW. L. Gore & Associates, Inc.2004-12-06MIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132609789PrimaryGS10
H373PTB0882753SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132609789007331326097897331326097890733132609789

GMDN Terms#

Term, Definition table
TermDefinition
Endoprosthetic portosystemic shuntA device intended to be permanently implanted to create or revise a transjugular intrahepatic portosystemic shunt (TIPS), a bypass for blood made between the portal and hepatic veins of the liver delivered to the liver via percutaneous access from the jugular vein, to treat portal hypertension and its complications (e.g., bleeding varices, gastropathy, ascites, and/or hepatic hydrothorax). It is a stent-like tube typically made of metal and polymer materials [e.g., nickel-titanium alloy (Nitinol), expanded polytetrafluoroethylene (ePTFE)] that expand upon implantation. It is implanted using a catheter delivery system and is available in various diameters (e.g., 8 - 12 mm).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Centimeter
Outer Diameter8Millimeter

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
00733132664177GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132664184GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132664191GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132664207GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132664214GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.MIR2025-10-29
00733132609741GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609758GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609765GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609772GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0842753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0852753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0862753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0872753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
H373PTB0882753GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609796GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609802GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609819GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609826GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609833GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609840GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609857GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132609864GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2017-02-13
00733132635009GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2016-12-13
00733132635016GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2016-12-13
00733132635023GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2016-12-13
00733132635030GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2016-12-13
00733132635047GORE VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.MIR2016-12-13
08714729203957WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMIR2015-03-24
08714729203964WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMIR2015-03-24
08714729203971WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMIR2015-03-24