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TORUS Stent Graft System

FDA UDI

Class III (US FDA UDI)

by PQ Bypass, Inc.

Identity

Trade Name
TORUS Stent Graft System FDA UDI
Generic Name
Central/peripheral venous endovascular stent-graft FDA UDI
Device Name
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 FDA UDI
Model / Reference
TSG-5.5X200 FDA UDI
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 FDA UDI

Identifiers

Catalog Number
TSG-5.5X200 FDA UDI
Primary DI / UDI-DI
00860008946416 FDA UDI
PMA Number
P220021 FDA UDI
FDA Product Code
QWM FDA UDI
GMDN Term
Central/peripheral venous endovascular stent-graft FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Central/peripheral venous endovascular stent-graft

TORUS Stent Graft System by PQ Bypass, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Central/peripheral venous endovascular stent-graft.

Cleared under the same submission

P220021 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PQ Bypass, Inc.

Sources (1)

  • FDA UDI 176f303b-4acf-43f4-951b-a06697a72ea9 38 fields · synced May 30, 2026