Fusion Bioline Vascular Graft— 510(k) K252445

Substantially Equivalent

Maquet Cardiovascular, LLC

FDA 510(k) clearance K252445 for Fusion Bioline Vascular Graft, Substantially Equivalent on 2026-04-27. Applicant: Maquet Cardiovascular, LLC.

Clearance details

Applicant: Maquet Cardiovascular, LLC
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2025-08-04
Decision date: 2026-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, 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.