VASCUTEK GELSOFT PLUS VASCULAR GRAFT— 510(k) K955230

Clearance details

Applicant

Vascutek, Ltd.

Product code

Code DSY

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

1995-11-14

Decision date

1996-02-09

Decision

Substantially Equivalent - Subject to Tracking Reg.

Clearance type

Traditional

Location

Austin, TX, US

• 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

• 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
• K162794 — Gelweave Vascular Grafts2017-06-30
• K093817 — GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS2010-01-07

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 →

• Z-2542-2021 — The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterileClass II·Terminated·Vascutek, Ltd.·20210708

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955230.