AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)— 510(k) K200697

Name: FDA 510(k) clearance K200697
Creator: U.S. Food and Drug Administration
Published: 2020-12-23

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K200697 for AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L), Substantially Equivalent on 2020-12-23. 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: 2020-03-17
Decision date: 2020-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

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