# K961847: Hemashield Vantage (Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Meadox Medicals, Div. Boston Scientific Corp.
- Decided: Jan 22, 1997 after 254 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
Longest line of descent: 2 generations back to P840029 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954848: Hemashield Microvel Velour Knitted Vascular Graft, Meadox Medicals, Div. Boston Scientific Corp. (1996) Summary page 1.

## Recalls of this device
- Jun 27, 2005 · Not classified · Z-1459-05: During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.

## Indications for use
For use in systemic vascular reconstructions, e.g., replacement in the case of aneurysmal or occlusive disease, in the peripheral region.

Source page: https://510kreport.com/device/K961847
Methodology: https://510kreport.com/methodology