FDA product code PFV: System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

PFV is the FDA product code for system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment. It is a Class III device, reviewed by the Cardiovascular panel. Devices under PFV reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 1 recall for PFV devices, 1 initiated in the last five years.

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.

Classification

Recalls for PFV devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-12-22.

Frequently asked questions

What is FDA product code PFV?

PFV is the FDA product code for system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment. It is a Class III device, reviewed by the Cardiovascular panel.

What device class is PFV?

Class III. Typical premarket route: PMA.

Have PFV devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2022-12-22.

Next steps

• Run an FDA pathway report with predicate devices for product code PFV
• Run a recall and safety report across every PFV manufacturer
• Watch product code PFV for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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