Gelweave Vascular Grafts— 510(k) K162794

Substantially Equivalent

Vascutek, Ltd.

FDA 510(k) clearance K162794 for Gelweave Vascular Grafts, Substantially Equivalent on 2017-06-30. Applicant: Vascutek, Ltd..

Clearance details

Applicant: Vascutek, Ltd.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2016-10-04
Decision date: 2017-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Inchinnan, GB

Download summary PDF View on FDA.gov ↗

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.