TORUS Stent Graft System

Primary DI
00860008946430
Brand
TORUS Stent Graft System
Company
PQ Bypass, Inc.
Model
TSG-6.0X150
Catalog number
TSG-6.0X150
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
2023-08-31
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
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
P220021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220021000DETOUR SystemEndologix, LLC2023-06-07QWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008946430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008946430008600089464308600089464300860008946430

GMDN Terms#

Term, Definition table
TermDefinition
Venous endovascular stent-graftA non-bioabsorbable tubular device designed to be implanted in a central 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 a mesh structure made of metal [e.g., nickel-titanium alloy (Nitinol)] 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 (e.g., self-expands or balloon-expandable) and disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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
050620329
Device count
1
Serial number
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008946447TORUS Stent Graft SystemTSG-6.0X200TSG-6.0X2002023-08-31
00860008946416TORUS Stent Graft SystemTSG-5.5X200TSG-5.5X2002023-08-31
00860008946423TORUS Stent Graft SystemTSG-6.0X100TSG-6.0X1002023-08-31
00860008946454TORUS Stent Graft SystemTSG-6.7X100TSG-6.7X1002023-08-31
00860008946461TORUS Stent Graft SystemTSG-6.7X150TSG-6.7X1502023-08-31
00860008946478TORUS Stent Graft SystemTSG-6.7X200TSG-6.7X2002023-08-31
00860008946409ENDOCROSS DeviceENDOCROSSENDOCROSS2023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850032145015TORUS Stent Graft SystemEndologix LLCQWM2026-01-27
00850032145022TORUS 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
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