# K162794: Gelweave Vascular Grafts

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Jun 30, 2017 after 269 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 K952293 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964665: Vascutek Gelweave Vascular Graft (Bifurcated Configuration), Carbomedics, Inc. (1997) Summary page 9.
- K013022: Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis, Sulzer Carbomedics, Inc. (2002) Summary page 9.
- K060142: Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers, Vascutek, Ltd. (2006) Summary page 9.
- K093817: Gelweave Branched Vascular Grafts with Radiopaque Markers, Vascutek, Ltd. (2010) Summary page 9.

## Most influential descendants
- K241550: Gelweave™ Vascular Prostheses (2025), 0 descendants of its own

## Indications for use
Indicated for thoracic reconstruction procedures for replacement of diseased segments of the thoracic aorta in cases of aneurysm, dissection, or coarctation. Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease. Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation. Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation. Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation. Gelweave branched vascular prostheses, including Siena™ vascular prostheses can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures.

Source page: https://510kreport.com/device/K162794
Methodology: https://510kreport.com/methodology