# K103080: Albograft Vascular Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Jan 19, 2011 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
Longest line of descent: 2 generations back to P840029 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has 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 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 or Woven Vascular Prosthesis (peripheral indication) are indicated for use in the replacement or repair of arteries affected with aneurismal or occlusive disease.

Source page: https://510kreport.com/device/K103080
Methodology: https://510kreport.com/methodology