FDA.reportPublic FDA data

GORE VIATORR TIPS Endoprosthesis

Primary DI
00733132609772
Brand
GORE VIATORR TIPS Endoprosthesis
Company
W. L. Gore & Associates, Inc.
Model
PTB087275
Catalog number
PTB087275
Device description
VIATORR ENDOPROTHESIS 8MMX7/2CM 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
00733132609772PrimaryGS10
H373PTB0872753SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132609772007331326097727331326097720733132609772

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
Length7Centimeter
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
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntHPT040015AHPT040015A2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntHPT050005AHPT050005A2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntHPT050015AHPT050015A2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntHPT060015AHPT060015A2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntHPT350005AHPT350005A2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntHPT350015AHPT350015A2017-02-13
00733132607068GORE PROPATEN Vascular GraftIRH060545AIRH060545A2017-02-13
00733132607129GORE PROPATEN Vascular GraftIRH463845AIRH463845A2017-02-13
00733132607143GORE PROPATEN Vascular GraftIRH473845AIRH473845A2017-02-13
00733132653690GORE SYNECOR Preperitoneal BiomaterialGKWR4040GKWR40402022-11-08
00733132653706GORE SYNECOR Preperitoneal BiomaterialGKWR3030GKWR30302022-11-08
00733132653713GORE SYNECOR Preperitoneal BiomaterialGKWR4050GKWR40502022-11-08
00733132653720GORE SYNECOR Preperitoneal BiomaterialGKWR3535GKWR35352022-11-08
00733132653737GORE SYNECOR Preperitoneal BiomaterialGKWR3040GKWR30402022-11-08
00733132653744GORE SYNECOR Preperitoneal BiomaterialGKWC09GKWC092021-10-05
00733132605798GORE PROPATEN Vascular GraftH060010AH060010A2017-02-13
00733132605811GORE PROPATEN Vascular GraftH060040AH060040A2017-02-13
00733132605835GORE PROPATEN Vascular GraftH060060AH060060A2017-02-13
00733132605859GORE PROPATEN Vascular GraftH060080AH060080A2017-02-13
00733132605873GORE PROPATEN Vascular GraftH080040AH080040A2017-02-13

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
00733132609789GORE 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