ATRICURE DISSECTOR— 510(k) K111020

Name: FDA 510(k) clearance K111020
Creator: U.S. Food and Drug Administration
Published: 2011-06-09

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K111020 for ATRICURE DISSECTOR, Substantially Equivalent on 2011-06-09. Applicant: AtriCure, Inc.. Device class: 2.

Clearance details

Applicant: AtriCure, Inc.
Product code: Code FTD
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2011-04-12
Decision date: 2011-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: West Chester, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.