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

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..

Clearance details

Applicant: Vascutek, Ltd.
Product code: Code DXZ
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 ↗

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.