Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts— 510(k) K162803

Substantially Equivalent

Vascutek, Ltd.

FDA 510(k) clearance K162803 for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts, Substantially Equivalent on 2017-07-14. Applicant: Vascutek, Ltd..

Clearance details

Applicant: Vascutek, Ltd.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2016-10-05
Decision date: 2017-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Inchinnan, GB

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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.