ATRICURE ABLATION SYSTEM— 510(k) K063630

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K063630 for ATRICURE ABLATION SYSTEM, Substantially Equivalent on 2007-01-26. Applicant: AtriCure, Inc..

Clearance details

Applicant: AtriCure, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2006-12-06
Decision date: 2007-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, OH, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.