DeviceClearance

K150996

Substantially Equivalent

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

Applicant
AtriCure, Inc.
Product code
FZP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
West Chester, OH, US
Download summary PDF View on FDA.gov ↗

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, through . 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.