GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS— 510(k) K093817

Name: FDA 510(k) clearance K093817
Creator: U.S. Food and Drug Administration
Published: 2010-01-07

Substantially Equivalent

Vascutek, Ltd.

FDA 510(k) clearance K093817 for GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS, Substantially Equivalent on 2010-01-07. Applicant: Vascutek, Ltd.. Device class: 2.

Clearance details

Applicant: Vascutek, Ltd.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 2009-12-11
Decision date: 2010-01-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Renfrewshire, Glasgow, GB

Download summary PDF View on FDA.gov ↗

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K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts2017-07-14
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K092863 — MAXIFLO, TAPERFLO2009-10-08

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 →

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