FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT— 510(k) K131778

Substantially Equivalent

Maquet Cardiovascular, LLC

FDA 510(k) clearance K131778 for FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT, Substantially Equivalent on 2013-11-14. Applicant: Maquet Cardiovascular, LLC.

Clearance details

Applicant: Maquet Cardiovascular, LLC
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 2013-06-17
Decision date: 2013-11-14
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.