cryoICE cryoXT cryoablation probe (cryoXT)— 510(k) K250371

Name: FDA 510(k) clearance K250371
Creator: U.S. Food and Drug Administration
Published: 2025-04-10

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K250371 for cryoICE cryoXT cryoablation probe (cryoXT), Substantially Equivalent on 2025-04-10. 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: 2025-02-10
Decision date: 2025-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

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