VASCUTEK CANNULA GRAFT, MODEL CGS2008S— 510(k) K081560

Clearance details

Applicant

Vascutek, Ltd.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2008-06-03

Decision date

2009-02-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Renfrewshire, Glasgow, GB

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• K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
• K253671 — Dual Stage Venous Cannulae2026-01-30

• K241550 — Gelweave Vascular Prostheses2025-02-27
• K241070 — Gelsoft Plus Vascular Prostheses2024-11-15
• K202703 — Vascutek Gelsoft Plus ERS Vascular Graft2021-04-06
• K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch2020-07-08
• K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts2017-07-14

Death

106

Injury

386

Malfunction

2,323

Total

2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →