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
00733132658855GORE® DrySeal Flex Introducer SheathGDSF1033GDSF10332024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathGDSF1045GDSF10452024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathGDSF1065GDSF10652024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathGDSF1133GDSF11332024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathGDSF1233GDSF12332024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathGDSF1245GDSF12452024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathGDSF1265GDSF12652024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathGDSF1433GDSF14332024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathGDSF1465GDSF14652024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathGDSF1533GDSF15332024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathGDSF1633GDSF16332024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathGDSF1665GDSF16652024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathGDSF1833GDSF18332024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathGDSF1865GDSF18652024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathGDSF2033GDSF20332024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathGDSF2065GDSF20652024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathGDSF2233GDSF22332024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathGDSF2265GDSF22652024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathGDSF2433GDSF24332024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathGDSF2465GDSF24652024-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741235979LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741235986LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741235993LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741236006LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741236013LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741236020LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
00801741236105LivertyAngiomed GmbH & Co. Medizintechnik KGMIR2026-10-07
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