SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS— 510(k) K013022

Name: FDA 510(k) clearance K013022
Creator: U.S. Food and Drug Administration
Published: 2002-06-13

Substantially Equivalent

Sulzer Carbomedics, Inc.

FDA 510(k) clearance K013022 for SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS, Substantially Equivalent on 2002-06-13. Applicant: Sulzer Carbomedics, Inc.. Device class: 2.

Clearance details

Applicant: Sulzer Carbomedics, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 2001-09-07
Decision date: 2002-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSY

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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

More clearances from Sulzer Carbomedics, Inc.

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K023185 — ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 8002002-12-17
K021051 — ANNULOFLO SYSTEM, MITRAL MODEL AR7002002-04-23
K002007 — SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS2001-01-25
K993288 — SULZER CARBOMEDICS CARDIOFIX PERICARDIUM1999-12-29
K992056 — ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF8001999-10-12

Adverse events under product code DSY

product code DSY

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 →

Recalls naming K013022

K-number listed on FDA's recall record

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 K013022.

Data sourced from openFDA. This site is unofficial and independent of the FDA.