# K013577: Ultramax Woven Velour Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: Jan 25, 2002 after 88 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
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.

## Indications for use
The Ultramax™ Woven Velour Vascular Graft is indicated for surgical repair, bypass or replacement of damaged vessels of the abdomen in cases of aneurysmal or occlusive disease.

Source page: https://510kreport.com/device/K013577
Methodology: https://510kreport.com/methodology