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FDA 510(k)

AtriCure cryoICE cryo-ablation probe (CRYO2)

K-Number: K180138 · 2018-02-15

ApplicantAtriCure, Inc.
Decision Date2018-02-15
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AtriCure cryoICE cryo-ablation probe (CRYO2) is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2018-02-15 under approval number K180138. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AtriCure cryoICE cryo-ablation probe (CRYO2)?

AtriCure cryoICE cryo-ablation probe (CRYO2) is a medical device that received FDA 510(k) clearance on 2018-02-15. It is manufactured by AtriCure, Inc.. The 510(k) number is K180138.

When was AtriCure cryoICE cryo-ablation probe (CRYO2) approved by the FDA?

AtriCure cryoICE cryo-ablation probe (CRYO2) received FDA 510(k) clearance on 2018-02-15, under approval number K180138.

What company makes AtriCure cryoICE cryo-ablation probe (CRYO2)?

AtriCure cryoICE cryo-ablation probe (CRYO2) is manufactured by AtriCure, Inc..

What is the FDA product code for AtriCure cryoICE cryo-ablation probe (CRYO2)?

The FDA product code for AtriCure cryoICE cryo-ablation probe (CRYO2) is GXH.

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Related Devices (Code: GXH)

K161835iovera systemMyoscience, Inc. K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. K173763iovera systemMyoscience, Inc. K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc. K211334Iovera SystemPacira Pharmaceuticals, Inc. K220656iovera SystemPacira Biosciences, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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