# K162803: Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Jul 14, 2017 after 282 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 P890045 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P890045: Gelseal TM Triaxial Vascular Graft, Carbomedics, Inc. (1993) Summary page 7.
- P890045/S001: Vascutek Gelsoft (TM) Vascular Graft, Carbomedics, Inc. (1995) Summary page 7.
- K990503: Sulzer Vascutek Gelsoft Vascular Prosthesis, Sulzermedica (1999) Summary page 7.
- K955230: Vascutek Gelsoft Plus Vascular Graft, Vascutek, Ltd. (1996) Summary page 7.

## Most influential descendants
- K241070: Gelsoft™ Plus Vascular Prostheses (2024), 0 descendants of its own

## Indications for use
Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease. Indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

Source page: https://510kreport.com/device/K162803
Methodology: https://510kreport.com/methodology