# K992958: Advanta Graft (<6MM)

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Oct 1, 1999 after 29 days
- Product code: DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 15 (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
- K231972: Advanta VXT Vascular Graft, Flixene Vascular Graft (2024), 0 descendants of its own

## Recalls of this device
- May 3, 2024 · Class II · Z-1954-2024: 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-1999-2024: 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-1993-2024: 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-1995-2024: 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-1996-2024: 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-1994-2024: 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-1997-2024: 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-1951-2024: 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-2001-2024: 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-1958-2024: 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-2000-2024: 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-1964-2024: 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-1962-2024: 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-1998-2024: 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-2313-2013: 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 (Wrapped) Advanta™ 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 (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.

Source page: https://510kreport.com/device/K992958
Methodology: https://510kreport.com/methodology