K122138

Substantially Equivalent

ATRIUM FLIXENE IFG VASCULAR GRAFT

Applicant: Atrium Medical Corp.
Product code: DSY
Advisory panel: Cardiovascular
Date received: 2012-07-19
Decision date: 2012-08-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Hudson, NH, US

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.