ATRICURE CRYO MODULE SYSTEM— 510(k) K140058

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K140058 for ATRICURE CRYO MODULE SYSTEM, Substantially Equivalent on 2014-01-24. Applicant: AtriCure, Inc..

Clearance details

Applicant: AtriCure, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2014-01-10
Decision date: 2014-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: West Chester, OH, US

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Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.