# K113101: Exxcel Soft Eptee Vascular Graft-Standard Wall,Thin Wall

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jan 17, 2012 after 90 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) EXXCEL Soft ePTFE Vascular Grafts: named in the summary without a submission number

## Most influential descendants
- K131778: Fusion Vascular Graft and Fusion Bioline Vascular Graft (2013), 2 descendants of its own
- K252445: Fusion Bioline Vascular Graft (2026), 0 descendants of its own
- K153523: FUSION Vascular Graft (2016), 0 descendants of its own

## Indications for use
Standard Wall EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal) and to provide vascular access. Thin Wall Exxcel Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal).

Source page: https://510kreport.com/device/K113101
Methodology: https://510kreport.com/methodology