# Vascutek, Ltd.

- Location (FDA's records): Renfrewshire, Glasgow, GB
- FDA decisions: 27 (1991–2025): 26 510(k) clearances and 1 original PMA approval
- Product codes: DSY (22), DXZ (2), QSK (1), DXC (1), DWF (1)
- 510(k) review time since 2016: median 269 days, against 269 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 25 (13 its own); citations of its devices by later devices: 23 (13 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Sulzermedica: 2 (https://510kreport.com/company/sulzermedica)
- Carbomedics, Inc.: 2 (https://510kreport.com/company/carbomedics)
- Mcpherson Enterprises, Inc.: 1 (https://510kreport.com/company/mcpherson-enterprises)
- Meadox Medicals, Div. Boston Scientific Corp.: 1 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)
- Impra, Inc.: 1 (https://510kreport.com/company/impra)
- 3M Health Care, Sarns: 1 (https://510kreport.com/company/3m-health-care-sarns)
- Sulzer Carbomedics, Inc.: 1 (https://510kreport.com/company/sulzer-carbomedics)

## Firms that cite its devices most
- Tayside Flow Technologies Limited: 2 (https://510kreport.com/company/tayside-flow-technologies)
- Sulzer Carbomedics, Inc.: 2 (https://510kreport.com/company/sulzer-carbomedics)
- Carbomedics, Inc.: 2 (https://510kreport.com/company/carbomedics)
- Cormatrix Cardiovascular, Inc.: 1 (https://510kreport.com/company/cormatrix-cardiovascular)
- Influence, Inc.: 1 (https://510kreport.com/company/influence)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Qura S.R.L: 1 (https://510kreport.com/company/qura)

## Its most-cited devices
- K963611: Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch (1996), cited by 4
- K952293: Vascutek Gelweave Vascular Graft (1995), cited by 4
- K060142: Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers (2006), cited by 2
- K041528: Modification to Eptfe Graft (2004), cited by 2
- K043552: Vascutek Ptfe Supported Eptfe Vascular Prostheses (2005), cited by 2
- K030999: Eptfe Vascular Prosthesis; Sealptfe (2003), cited by 1

## Recent decisions
- K241550: Gelweave™ Vascular Prostheses (Feb 27, 2025)
- K241070: Gelsoft™ Plus Vascular Prostheses (Nov 15, 2024)
- P210006: Thoraflex™ Hybrid (Apr 19, 2022)
- K202703: Vascutek Gelsoft Plus ERS Vascular Graft (Apr 6, 2021)
- K200955: Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (Jul 8, 2020)
- K162803: Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (Jul 14, 2017)
- K162794: Gelweave Vascular Grafts (Jun 30, 2017)
- K093817: Gelweave Branched Vascular Grafts with Radiopaque Markers (Jan 7, 2010)

Source page: https://510kreport.com/company/vascutek