# K964665: Vascutek Gelweave Vascular Graft (Bifurcated Configuration)

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Feb 19, 1997 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
Longest line of descent: 1 generation back to K952293 (1995). 1 ancestor in all.
2 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)
- K952293: Vascutek Gelweave Vascular Graft, Vascutek, Ltd. (1995) Summary page 1.

## Most influential descendants
- K162794: Gelweave Vascular Grafts (2017), 1 descendant of its own
- K241550: Gelweave™ Vascular Prostheses (2025), 0 descendants of its own

## Indications for use
The Gelweave™ vascular graft (bifurcated configuration) is indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.

Source page: https://510kreport.com/device/K964665
Methodology: https://510kreport.com/methodology