SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS— 510(k) K990503

Name: FDA 510(k) clearance K990503
Creator: U.S. Food and Drug Administration
Published: 1999-12-09

Substantially Equivalent

Sulzermedica

FDA 510(k) clearance K990503 for SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS, Substantially Equivalent on 1999-12-09. Applicant: Sulzermedica. Device class: 2.

Clearance details

Applicant: Sulzermedica
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1999-02-17
Decision date: 1999-12-09
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 Sulzermedica

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K002324 — MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA2000-08-24
K993667 — SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS2000-01-28
K993569 — APR METASUL ACETABULAR INSERT1999-12-01
K992832 — SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS1999-11-19

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 K990503

K-number listed on FDA's recall record

Z-0336-2014 — Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***" The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteriesClass II·Terminated·Terumo Cardiovascular Systems Corporation·20131023

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990503.

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