K151386

Substantially Equivalent

C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic

Applicant: Atrium Medical Corporation
Product code: FTL
Advisory panel: General, Plastic Surgery
Date received: 2015-05-26
Decision date: 2015-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, US

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.