FDA.report

GORE EXCLUDER AAA Endoprosthesis with C3 Delivery

Primary DI
00733132622511
Company
W. L. Gore & Associates, Inc.
Model
RLT281218
Catalog number
RLT281218
Device description
Trunk-Ipsilateral Leg
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
967358115
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00733132622511PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00733132622511PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment3UnknownYIneligible

Premarket Submissions

SubmissionSupplement
P020004092

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P020004092EXCLUDER BIFURCATED ENDOPROSTHESISW.L. GORE & ASSOCIATES,INC2002-11-06MIH

GMDN Terms

TermDefinition
Abdominal aorta endovascular stent-graftA sterile non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries.

Device Sizes

TypeValueText
Length18 Centimeter
Outer Diameter12 Millimeter
Outer Diameter28.5 Millimeter

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
8005288763mpdcustomercare@wlgore.com

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00733132663828GORE® VIABAHN® FORTEGRA Venous StentVNS181002AVNS181002A2026-01-08
00733132663835GORE® VIABAHN® FORTEGRA Venous StentVNS180702AVNS180702A2026-01-08
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00733132663859GORE® VIABAHN® FORTEGRA Venous StentVNS161502AVNS161502A2026-01-08
00733132663866GORE® VIABAHN® FORTEGRA Venous StentVNS161002AVNS161002A2026-01-08
00733132663873GORE® VIABAHN® FORTEGRA Venous StentVNS160702AVNS160702A2026-01-08

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