# K122138: Atrium Flixene Ifg Vascular Graft

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Aug 17, 2012 after 29 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jul 12, 2013 · Class II · Z-2307-2013: 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 IFG Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Source page: https://510kreport.com/device/K122138
Methodology: https://510kreport.com/methodology