TORUS Stent Graft System

Basic Information

• Brand Name: TORUS Stent Graft System
• Primary DI: 00860008946447
• Version / Model: TSG-6.0X200
• Catalog Number: TSG-6.0X200
• Company Name: PQ Bypass, Inc.
• Labeler DUNS: 050620329
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-31
• Public Version: 1
• Public Version Date: 2023-09-08
• Public Version Status: New
• Public Device Record Key: 26bc7360-5f04-4713-86cd-4cbaeb420387

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QWM	Stent Graft, Bypass, Superficial Femoral Artery	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61856	Venous endovascular stent-graft	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008946447	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P220021	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6.0 mm Stent Graft Proximal Diameter
Device Size Text, specify			6.0 mm Stent Graft Distal Diameter
Device Size Text, specify			135cm Catheter Working Length
Device Size Text, specify			6F Delivery System Outer Profile
Device Size Text, specify			200mm Covered Stent Graft Length

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.