# K130016: Lifespan Eptfe Vascular Graft

- Pathway: 510(k) (Special)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Feb 5, 2013 after 35 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933590 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933590: Baxter Reinforced Expanded Ptfe Vascular Graft, Baxter Healthcare Corp (1994) Summary page 1.
- K944844: Baxter Reinforced Expanded Ptfe Stepped Vascular Graft, Baxter Healthcare Corp (1995) Summary page 1.
- K944858: Baxter Eptfe Externally Supported Vascular Grafts, Baxter Edwards (1995) Summary page 1.
- K032900: Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts, Edwards Lifesciences, LLC (2003) Summary page 1.

## Indications for use
The LeMaitre LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.

Source page: https://510kreport.com/device/K130016
Methodology: https://510kreport.com/methodology