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U.S. Department of Health and Human Services

Product Classification

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Device system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Definition An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
Physical State The endovascular stent-graft is a metal scaffold covered with fabric material. The stent-graft is placed via a delivery catheter into the arteriovenous dialysis access circuit to maintain or re-establish vessel patency for hemodialysis. The endovascular stent-grafts are available in various diameters and lengths.
Technical Method Generally, a Peripheral Transluminal Angioplasty (PTA) catheter is used initially to open up the occlusion and allow for passage of the endovascular graft delivery system to pass through. The endovascular graft is then deployed at the site of the occlusion with the structural stent component propping open the vessel. The covered stent assists in maintaining vessel patency post-procedure.
Target Area Stenotic lesions or thrombotic occlusions in the arteriovenous dialysis access circuit, including the venous anastomosis.
Review Panel Cardiovascular
Product CodePFV
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible