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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
PQ Bypass, Inc.
TSG-6.0X150
In Commercial Distribution

  • 00860008946430 ()

  • 6.0mm Stent Graft Proximal Diameter
  • 6.0mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • Covered Stent Graft Length
TSG-6.0X150

  • Central/peripheral venous endovascular stent-graft
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
PQ Bypass, Inc.
TSG-6.0X100
In Commercial Distribution

  • 00860008946423 ()

  • 6.0 mm Stent Graft Proximal Diameter
  • 6.0 mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 100 mm Covered Stent Graft Length
TSG-6.0X100

  • Central/peripheral venous endovascular stent-graft
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
PQ Bypass, Inc.
TSG-5.5X200
In Commercial Distribution

  • 00860008946416 ()

  • 5.5 mm Stent Graft Proximal Diameter
  • 5.5 mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 200 mm Covered Stent Graft Length
TSG-5.5X200

  • Central/peripheral venous endovascular stent-graft
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.
PQ Bypass, Inc.
ENDOCROSS
In Commercial Distribution

  • 00860008946409 ()
ENDOCROSS

  • Vascular guide-catheter, single-use
PASCAL TABLE US COMMERCIAL
Edwards Lifesciences LLC
10000T
In Commercial Distribution

  • 00690103216981 ()
10000TA

  • Cardiac implantation catheter table
PASCAL SYSTEM - STABILIZER RAIL SYSTEM
Edwards Lifesciences LLC
20000ST
In Commercial Distribution

  • 00690103216974 ()
20000STA

  • Cardiac implantation catheter holder
PASCAL PRECISION SYSTEM - GUIDE SHEATH
Edwards Lifesciences LLC
20000GSA
In Commercial Distribution

  • 00690103216967 ()
20000GSA

  • Heart valve clip
PASCAL PRECISION SYSTEM – PASCAL ACE IMPLANT SYSTEM
Edwards Lifesciences LLC
20000ISM
In Commercial Distribution

  • 00690103216950 ()
20000ISMA

  • Heart valve clip
PASCAL PRECISION SYSTEM – IMPLANT SYSTEM
Edwards Lifesciences LLC
20000IS
In Commercial Distribution

  • 00690103216943 ()
20000ISA

  • Heart valve clip
No Description
Edwards Lifesciences LLC
916ES
In Commercial Distribution

  • 00690103193992 ()

  • 16F
916ESA

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
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