# K093231: Albograft Vascular Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Jan 14, 2010 after 92 days
- Product code: MAL (Graft, Vascular, Synthetic/Biologic Composite)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 17 (17 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.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Jun 17, 2013 · Class I · Z-1756-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1762-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1770-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1760-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1765-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1764-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1754-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1757-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1767-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1769-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1766-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1759-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1768-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1755-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1761-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1758-2013: Blood blushing/leaking from the surface of the graft after implantation
- Jun 17, 2013 · Class I · Z-1763-2013: Blood blushing/leaking from the surface of the graft after implantation

## Indications for use
The AlboGraft Double Velour Knitted and Woven Grafts are indicated for use in the replacement or repair of Abdominal and Thoracic arteries affected with aneurysmal or occlusive disease.

Source page: https://510kreport.com/device/K093231
Methodology: https://510kreport.com/methodology