# K013022: Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Carbomedics, Inc.
- Decided: Jun 13, 2002 after 279 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). 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

## 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
The Sulzer VascutekO Gelweave Valsalva'" Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.

Source page: https://510kreport.com/device/K013022
Methodology: https://510kreport.com/methodology