# K052302: Hemashield Platinum Woven Double Velour Taaa Graft Configuration

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Sep 12, 2005 after 19 days
- Product code: MAL (Graft, Vascular, Synthetic/Biologic Composite)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 Platinum Woven Double Velour Vascular Grafts: named in the summary without a submission number

## Most influential descendants
- K070323: Temporary Limb Salvage Shunt (2007), 0 descendants of its own

## Recalls of this device
- Apr 7, 2020 · Class II · Z-1862-2020: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
- Apr 7, 2020 · Class II · Z-1863-2020: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
- May 24, 2010 · Not classified · Z-2065-2010: 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 PLATINUMTM 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/K052302
Methodology: https://510kreport.com/methodology