Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch— 510(k) K200955

Name: FDA 510(k) clearance K200955
Creator: U.S. Food and Drug Administration
Published: 2020-07-08

Substantially Equivalent

Vascutek, Ltd.

FDA 510(k) clearance K200955 for Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch, Substantially Equivalent on 2020-07-08. Applicant: Vascutek, Ltd.. Device class: 2.

Clearance details

Applicant: Vascutek, Ltd.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2020-04-09
Decision date: 2020-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Inchinnan, GB

Download summary PDF View on FDA.gov ↗

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K202703 — Vascutek Gelsoft Plus ERS Vascular Graft2021-04-06
K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts2017-07-14
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Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.