K122612

Substantially Equivalent

HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX

Applicant: Maquet Cardiovascular, LLC
Product code: MAL
Advisory panel: Cardiovascular
Date received: 2012-08-27
Decision date: 2012-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Adverse events under product code MAL

product code MAL

Death: 4
Total: 4

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.