# K071923: Ptfe Flixene Graduated Wall Graft

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Aug 14, 2007 after 33 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K231972: Advanta VXT Vascular Graft, Flixene Vascular Graft (2024), 0 descendants of its own
- K093934: Gore Hybrid Vascular Graft (2010), 0 descendants of its own

## 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-2314-2013: 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 Graduated Wall Flixene Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Source page: https://510kreport.com/device/K071923
Methodology: https://510kreport.com/methodology