# K090987: Vascutek Branched Gelweave

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Jun 19, 2009 after 73 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: 1 generation back to K952293 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
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.
- K040829: Gelweave Ante-Flo with Collar and Gelweave 4 Branch Plexus with Collar, Vascutek, Ltd. (2004) Summary page 1.
- K060142: Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers, Vascutek, Ltd. (2006) Summary page 1.

## Recalls of this device
- Jul 8, 2021 · Class II · Z-2542-2021: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

## Indications for use
Gelweave branched vascular grafts: “Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation”. Gelweave Siena vascular grafts with and without radiopaque markers: “Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation”. “Gelweave branched vascular grafts, including Siena grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures”.

Source page: https://510kreport.com/device/K090987
Methodology: https://510kreport.com/methodology