Advanta VXT Vascular Graft, Flixene Vascular Graft— 510(k) K231972

Substantially Equivalent

Atrium Medical Corporation

FDA 510(k) clearance K231972 for Advanta VXT Vascular Graft, Flixene Vascular Graft, Substantially Equivalent on 2024-03-28. Applicant: Atrium Medical Corporation.

Clearance details

Applicant: Atrium Medical Corporation
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2023-07-03
Decision date: 2024-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Merrimack, NH, US

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.