# K992441: Advanta Graft

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Aug 20, 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: 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-2309-2013: 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 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 Advanta™ Graft use in aortocronary bypass applications or for use as a patch.

Source page: https://510kreport.com/device/K992441
Methodology: https://510kreport.com/methodology