FDA.reportPublic FDA data

TORUS Stent Graft System

Primary DI
00850032145022
Brand
TORUS Stent Graft System
Company
Endologix LLC
Model
TSG-6.0X100
Catalog number
TSG-6.0X100
Device description
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
Published
2026-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QWMStent Graft, Bypass, Superficial Femoral Artery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWMStent Graft, Bypass, Superficial Femoral ArteryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220021006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220021006DETOUR SystemEndologix, LLC2023-06-07QWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032145022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032145022008500321450228500321450220850032145022

GMDN Terms#

Term, Definition table
TermDefinition
Central/peripheral venous endovascular stent-graftA non-bioabsorbable tubular device designed to be implanted in a central and/or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis; it is not intended for coronary or intracranial venous stenting. It is a mesh structure made of metal [e.g., nickel-titanium alloy] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ and disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(949) 595-7200CustomerService@endologix.com

Regulatory Flags#

DUNS number
179593652
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007370152Ovation iX Iliac Stent GraftTV-IL141280-JTV-IL141280-J2023-03-03
00850007370169Ovation iX Iliac Stent GraftTV-IL1412100-JTV-IL1412100-J2023-03-03
00850007370176Ovation iX Iliac Stent GraftTV-IL1412120-JTV-IL1412120-J2023-03-03
00850007370183Ovation iX Iliac Stent GraftTV-IL1412140-JTV-IL1412140-J2023-03-03
00850007370213Ovation iX Iliac Stent GraftTV-IL1414120-JTV-IL1414120-J2023-03-03
00850007370411Ovation iX Iliac Stent GraftTV-IL1412160-JTV-IL1412160-J2023-03-03
00850007370428Ovation iX Iliac Stent GraftTV-IL1414100-JTV-IL1414100-J2023-03-03
00850007370091Ovation iX Iliac Stent GraftTV-IL1428140-JTV-IL1428140-J2023-03-02
00850007370107Ovation iX Iliac Stent GraftTV-IL141480-JTV-IL141480-J2023-03-02
00850007370114Ovation iX Iliac Stent GraftTV-IL1410160-JTV-IL1410160-J2023-03-02
00850007370190Ovation iX Iliac Stent GraftTV-IL1428120-JTV-IL1428120-J2023-03-02
00850007370206Ovation iX Iliac Stent GraftTV-IL1428100-JTV-IL1428100-J2023-03-02
00850007370220Ovation iX Iliac Stent GraftTV-IL1414140-JTV-IL1414140-J2023-03-02
00850007370237Ovation iX Iliac Stent GraftTV-IL141680-JTV-IL141680-J2023-03-02
00850007370244Ovation iX Iliac Stent GraftTV-IL1416100-JTV-IL1416100-J2023-03-02
00850007370251Ovation iX Iliac Stent GraftTV-IL1416120-JTV-IL1416120-J2023-03-02
00850007370268Ovation iX Iliac Stent GraftTV-IL1416140-JTV-IL1416140-J2023-03-02
00850007370275Ovation iX Iliac Stent GraftTV-IL141880-JTV-IL141880-J2023-03-02
00850007370282Ovation iX Iliac Stent GraftTV-IL1418100-JTV-IL1418100-J2023-03-02
00850007370299Ovation iX Iliac Stent GraftTV-IL1418120-JTV-IL1418120-J2023-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850032145015TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145039TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145046TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145053TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145060TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145077TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145008ENDOCROSS DeviceEndologix LLCQWM2025-09-24
00860008946409ENDOCROSS DevicePQ Bypass, Inc.QWM2023-08-31
00860008946416TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946423TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946430TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946447TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946454TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946461TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31
00860008946478TORUS Stent Graft SystemPQ Bypass, Inc.QWM2023-08-31