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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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St. Jude Medical Valved Graft HP Rotatable Mechanical Heart Valve
ST. JUDE MEDICAL, INC.
19VAVGJ-515
In Commercial Distribution

  • 05414734009485 ()

  • Outer Diameter: 19 Millimeter
19VAVGJ-515

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta 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-6.7X200
In Commercial Distribution

  • 00860008946478 ()

  • 6.7mm Stent Graft Proximal Diameter
  • 6.7mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 200mm Covered Stent Graft Length
TSG-6.7X200

  • 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-6.7X150
In Commercial Distribution

  • 00860008946461 ()

  • 6.7mm Stent Graft Proximal Diameter
  • 6.7mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 150mm Covered Stent Graft Length
TSG-6.7X150

  • 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-6.7X100
In Commercial Distribution

  • 00860008946454 ()

  • 6.7mm Stent Graft Proximal Diameter
  • 6.7mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 100mm Covered Stent Graft Length
TSG-6.7X100

  • 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-6.0X200
In Commercial Distribution

  • 00860008946447 ()

  • 6.0 mm Stent Graft Proximal Diameter
  • 6.0 mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 6F Delivery System Outer Profile
  • 200mm Covered Stent Graft Length
TSG-6.0X200

  • 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-6.0X150
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
The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL141080-J
In Commercial Distribution

  • 00850007370992 ()

  • Stent Diameter: 14 Millimeter
  • Stent Diameter: 10 Millimeter
  • Catheter Working Length: 60 Centimeter
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 80 Millimeter
TV-IL141080-J

  • Abdominal aorta endovascular stent-graft
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