# K060124: Atrium Flixene Graft

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Mar 30, 2006 after 71 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 18 (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. The FDA summary names no predicate by number.

## Recalls of this device
- May 3, 2024 · Class II · Z-2003-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2010-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2015-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2012-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2009-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2002-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2006-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2013-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2007-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2008-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2014-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2011-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2004-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2018-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2005-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2017-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- May 3, 2024 · Class II · Z-2016-2024: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- Jul 12, 2013 · Class II · Z-2310-2013: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field

## Indications for use
The Atrium Flixene Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Flixene Graft use in aortocoronary bypass applications or for use as a patch.

Source page: https://510kreport.com/device/K060124
Methodology: https://510kreport.com/methodology