# K051332: Advanta T-Graft

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: Sep 29, 2005 after 129 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K093934: Gore Hybrid Vascular Graft (2010), 0 descendants of its own

## Recalls of this device
- Jul 12, 2013 · Class II · Z-2305-2013: 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 AdvantaTM T-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 AdvantaTM T-Graft use in aortocoronary bypass applications or for use as a patch.

Source page: https://510kreport.com/device/K051332
Methodology: https://510kreport.com/methodology