Atricure Cryo Module System; cryoICE cryoablation probe— 510(k) K142203

Name: FDA 510(k) clearance K142203
Creator: U.S. Food and Drug Administration
Published: 2014-11-25

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K142203 for Atricure Cryo Module System; cryoICE cryoablation probe, Substantially Equivalent on 2014-11-25. 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: 2014-08-11
Decision date: 2014-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, OH, US

Download summary PDF View on FDA.gov ↗

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