FDA 510(k) Applications Submitted by Melissa Smallwood

FDA 510(k) Number Submission Date Device Name Applicant
K180137 01/17/2018 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc.
K180138 01/17/2018 AtriCure cryoICE cryo-ablation probe (CRYO2) AtriCure, Inc.
K190151 01/30/2019 COBRA Fusion Ablation System AtriCure, Inc.
K210477 02/19/2021 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE AtriCure Inc.
K200697 03/17/2020 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) AtriCure Inc.
K172742 09/12/2017 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) AtriCure, Inc.
K173031 09/28/2017 AtriClip LAA Exclusion System with Preloaded PRO╖V Clip AtriCure, Inc.
K163408 12/05/2016 Isolator Multifunctional Linear Pen AtriCure Inc.


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