# K231972: Advanta VXT Vascular Graft, Flixene Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corporation
- Decided: Mar 28, 2024 after 269 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992960 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992960: Advanta Graft (>6MM), Atrium Medical Corp. (1999) Summary page 6.
- K992958: Advanta Graft (<6MM), Atrium Medical Corp. (1999) Summary page 6.
- K071923: Ptfe Flixene Graduated Wall Graft, Atrium Medical Corp. (2007) Summary page 6.

## Indications for use
Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.

Source page: https://510kreport.com/device/K231972
Methodology: https://510kreport.com/methodology