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

PFV · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: PFV
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 15

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown