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FDA 510(k) Applications Submitted by ATRICURE INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K163261
11/21/2016
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
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.
K163408
12/05/2016
Isolator Multifunctional Linear Pen
AtriCure Inc.
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