K172742

Substantially Equivalent

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)

Applicant: AtriCure, Inc.
Product code: FZP
Advisory panel: General, Plastic Surgery
Date received: 2017-09-12
Decision date: 2017-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Mason, OH, US

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.