# K012952: Hemashield Gold Woven Double Velour Vascular Graft - Branch Graft

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific/Medi-Tech
- Decided: Oct 2, 2001 after 28 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
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. The FDA summary names its predicate without a number.
- (no number) Hemashield Gold Woven Double Velour Vascular Graft: named in the summary without a submission number

## Recalls of this device
- May 24, 2010 · Not classified · Z-2061-2010: Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially com

## Indications for use
The Hemashield Gold ™ Woven Double Velour Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Source page: https://510kreport.com/device/K012952
Methodology: https://510kreport.com/methodology