Manufacturer's Devices - W.L. Gore & Associates Inc.

Address:




1505 N. Fourth Street



Flagstaff

Arizona 86004

United States


Authorised Representative/ UK Responsible Person
Name: W. L. Gore & Associates (UK) Ltd.
Address:

Simpson Parkway Kirkton Campus



Livingston

West Lothian EH54 7BH

United Kingdom




Code/Term Type
Synthetic vascular graftSynthetic vascular graftClass III
Abdominal aorta endovascular stent-graft non-medicatedAbdominal aorta endovascular stent-graft non-medicatedClass III
Cardiac defect occluderCardiac defect occluderClass III
Endoprosthetic portosystemic shuntEndoprosthetic portosystemic shuntClass IIb
Extra-gynaecological surgical mesh composite-polymerExtra-gynaecological surgical mesh composite-polymerClass III
Extra-gynaecological surgical mesh synthetic polymer bioabsorbableExtra-gynaecological surgical mesh synthetic polymer bioabsorbableClass III
Extra-gynaecological surgical mesh synthetic polymer non-bioabsorbableExtra-gynaecological surgical mesh synthetic polymer non-bioabsorbableClass IIb
Haemostasis valveHaemostasis valveClass IIa
Pericardium prosthesisPericardium prosthesisClass III
Peripheral angioplasty balloon catheter basicPeripheral angioplasty balloon catheter basicClass III
Polymer-metal biliary stent non-bioabsorbablePolymer-metal biliary stent non-bioabsorbableClass IIb
Extra-gynaecological surgical mesh synthetic polymer bioabsorbableExtra-gynaecological surgical mesh synthetic polymer bioabsorbableClass III
Polymer-metal biliary stent non-bioabsorbablePolymer-metal biliary stent non-bioabsorbableClass IIb
Intravascular occluding/stent-graft post-dilation balloon catheterIntravascular occluding/stent-graft post-dilation balloon catheterClass III
Aortic endovascular implant post-dilation balloon catheterAortic endovascular implant post-dilation balloon catheterClass III
Peripheral artery stent bare-metalPeripheral artery stent bare-metal Conformity Assessment Certificate ExpiredClass III
Abdominal aorta endovascular stent-graft non-medicatedAbdominal aorta endovascular stent-graft non-medicatedClass III
Cardiac defect occluderCardiac defect occluderClass III
Descending thoracic aorta endovascular stent-graftDescending thoracic aorta endovascular stent-graftClass III
Descending thoracic aorta endovascular stent-graftDescending thoracic aorta endovascular stent-graftClass III
Endoprosthetic portosystemic shuntEndoprosthetic portosystemic shuntClass IIb
Cardiovascular patch syntheticCardiovascular patch syntheticClass III
Peripheral artery stent bare-metalPeripheral artery stent bare-metalClass III
Polyolefin suture monofilamentPolyolefin suture monofilamentClass III
Synthetic vascular graftSynthetic vascular graftClass III