# K131778: Fusion Vascular Graft and Fusion Bioline Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiovascular, LLC
- Decided: Nov 14, 2013 after 150 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K791810 (1979). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962433: Meadox Exxcel Eptfe Vascular Graft, Meadox Medicals, Div. Boston Scientific Corp. (1997) Summary page 1.
- K052964: Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven, Boston Scientific Corp (2006) Summary page 1.
- K113101: Exxcel Soft Eptee Vascular Graft-Standard Wall,Thin Wall, Boston Scientific Corporation (2012) Summary page 1.

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

## Recalls of this device
- Jan 30, 2023 · Class II · Z-1245-2023: One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may res

## Indications for use
FUSION™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.

Source page: https://510kreport.com/device/K131778
Methodology: https://510kreport.com/methodology