FDA.reportPublic FDA data

GORE VIABAHN VBX Balloon Expandable Endo

Primary DI
00733132658282
Brand
GORE VIABAHN VBX Balloon Expandable Endo
Company
W. L. Gore & Associates, Inc.
Model
BXB051902A
Catalog number
BXB051902A
Device description
BX2 HEP REDUCED PROFILE BX2 5MMX19MM 6Fr 135CM Cath
Published
2023-12-11
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
PRLIliac covered stent, arterial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRLIliac Covered Stent, ArterialUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160021039

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160021039GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESISW. L. Gore & Associates, Inc.2017-01-27PRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132658282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132658282007331326582827331326582820733132658282

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery endovascular stent-graft, drug-coatedA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary and intracranial arteries) to maintain patency and improve luminal diameter, and that includes a heparin coating intended to prevent thrombotic vessel re-narrowing; it may in addition be intended for optional implantation in the common iliac arteries which extends beyond the aortic bifurcation, or for venous implantation. It is comprised of a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft). It is percutaneously inserted to the site of implantation with a disposable delivery device which may be included with the stent-graft.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length1.9Centimeter
Lumen/Inner Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-528-8763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
Combination product
true
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
00650862122916iCast covered stent system, 12mm x 29mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862122923iCast covered stent system, 12mm x 29mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862124118iCast covered stent system, 12mm x 41mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862124125iCast covered stent system, 12mm x 41mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862126112iCast covered stent system, 12mm x 61mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862126129iCast covered stent system, 12mm x 61mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862425321iCast covered stent system, 5mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862426328iCast covered stent system, 6mm x 32mm x 120cm Atrium Medical CorporationPRL2026-02-18
00650862427325iCast covered stent system, 7mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862428322iCast covered stent system, 8mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862429329iCast covered stent system, 9mm x 32mm x 120cmAtrium Medical CorporationPRL2026-02-18
00650862480597iCast covered stent system, 10mm x 59mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862485325iCast covered stent system, 5mm x 32mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862486322iCast covered stent system, 6mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862487329iCast covered stent system, 7mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862488326iCast covered stent system, 8mm x 32mm x 80cm Atrium Medical CorporationPRL2026-02-18
00650862489323iCast covered stent system, 9mm x 32mm x 80cmAtrium Medical CorporationPRL2026-02-18
00650862720594iCast covered stent system, 10mm x 59mm x 120cmAtrium Medical CorporationPRL2026-02-18
00733132658251GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658268GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658275GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658299GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658305GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658312GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658329GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658336GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658343GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658350GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658367GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11
00733132658374GORE VIABAHN VBX Balloon Expandable EndoW. L. Gore & Associates, Inc.PRL2023-12-11