Product code PFV

Device name

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

Medical specialty

Unknown

Device class

3

Review panel

CV

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset