# P060002: Flair Endovascular Stent Graft

- Pathway: PMA
- Applicant: Bard Peripheral Vascular
- Decided: Jul 23, 2007 after 552 days
- Product code: PFV (System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 19, 2015 · Class II · Z-0223-2016: Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use.

Source page: https://510kreport.com/device/P060002
Methodology: https://510kreport.com/methodology