System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·Covera Vascular Covered Stent

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Syringe, Balloon Inflation

FDA classification

FDA Class 2 ·Syringe, Balloon Inflation

Graft, Bypass, Coronary Artery

FDA classification

Graft, Bypass, Coronary Artery

AVS INNOVATION

Importer

🇫🇷 France

Syringe, Balloon Inflation, Exempt

FDA classification

FDA Class 2 ·Syringe, Balloon Inflation, Exempt

AV Medical CZ s.r.o.

Importer

🇨🇿 Czechia

Cannula, A-V Shunt

FDA classification

FDA Class 2 ·Cannula, A-V Shunt

Accessories, A-V Shunt

FDA classification

FDA Class 2 ·Accessories, A-V Shunt

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA classification

FDA Class 3 ·System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

Adapter, A-V Shunt Or Fistula

FDA classification

FDA Class 2 ·Adapter, A-V Shunt Or Fistula

Polytech Domilens GmbH

Importer

🇩🇪 Germany·13 Manufacturers

W.M.BLOSS, S.A

Importer

🇪🇸 Spain·20 Manufacturers

ITD 2406494 1

Certificate

MDR QA·AUTEL S.r.l.·TUV Rheinland Italia SRL

ITD 1344523 1

Certificate

MDR QA·Dispotech srl·TUV Rheinland Italia SRL

DZ 2111577-1

Certificate

MDR QA·SHAOXING YIBON MEDICAL CO., LTD.·TÜV Rheinland LGA Products GmbH