# P020004: Excluder Bifurcated Endoprosthesis

- Pathway: PMA
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Nov 6, 2002 after 287 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 2 (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
- Jan 6, 2020 · Class II · Z-0996-2020: Firm has received reports of leading end catheter component separations.
- Jan 6, 2020 · Class II · Z-0995-2020: Firm has received reports of leading end catheter component separations.

Source page: https://510kreport.com/device/P020004
Methodology: https://510kreport.com/methodology