Vascutek Gelsoft Plus ERS Vascular Graft— 510(k) K202703

Clearance details

Applicant

Vascutek, Ltd.

Product code

Code DSY

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

2020-09-16

Decision date

2021-04-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Inchinnan, GB

• K252445 — Fusion Bioline Vascular Graft2026-04-27
• K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)2025-10-20
• K241550 — Gelweave Vascular Prostheses2025-02-27
• K241070 — Gelsoft Plus Vascular Prostheses2024-11-15
• K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

• 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
• 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 →