AtriCure cryoICE BOX (ACM)— 510(k) K243157

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K243157 for AtriCure cryoICE BOX (ACM), Substantially Equivalent on 2024-10-29. Applicant: AtriCure, Inc.. Device class: 2.

Clearance details

Applicant: AtriCure, Inc.
Product code: Code GXH
Device class: Class 2
Regulation: 21 CFR 882.4250
Advisory panel: Neurology
Date received: 2024-09-30
Decision date: 2024-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

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