Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts— 510(k) K162803

Clearance details

Applicant

Vascutek, Ltd.

Product code

Code DSY

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

2016-10-05

Decision date

2017-07-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Inchinnan, GB

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• K202703 — Vascutek Gelsoft Plus ERS Vascular Graft2021-04-06
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• K162794 — Gelweave Vascular Grafts2017-06-30
• K093817 — GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS2010-01-07
• K092863 — MAXIFLO, TAPERFLO2009-10-08

Death

29

Injury

694

Total

723

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 →