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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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