AtriClip FLEX-Mini LAA Exclusion System (ACHM)— 510(k) K234125

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K234125 for AtriClip FLEX-Mini LAA Exclusion System (ACHM), Substantially Equivalent on 2024-07-29. Applicant: AtriCure, Inc..

Clearance details

Applicant: AtriCure, Inc.
Product code: Code PZX
Advisory panel: General, Plastic Surgery
Date received: 2023-12-28
Decision date: 2024-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PZX

product code PZX

Death: 6
Total: 6

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.