ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)— 510(k) K121507

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K121507 for ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE), Substantially Equivalent on 2012-06-06. Applicant: AtriCure, Inc..

Clearance details

Applicant: AtriCure, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2012-05-21
Decision date: 2012-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
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.