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AtriCure, Inc.

59 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056)AtriCure, Inc.2025-07-24
cryoICE cryoXT cryoablation probe (cryoXT) (K250371)AtriCure, Inc.2025-04-10
AtriClip PRO-Mini LAA Exclusion System (PROM) (K243860)AtriCure, Inc.2025-01-15
AtriCure cryoICE BOX (ACM) (K243157)AtriCure, Inc.2024-10-29
Isolator Synergy EnCapture Ablation System (EMH) (K234151)AtriCure, Inc.2024-08-27
AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125)AtriCure, Inc.2024-07-29
EPi-Ease Epicardial Access Device (EAS) (K233959)AtriCure, Inc.2024-02-13
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) (K233407)AtriCure, Inc.2023-11-02
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) (K233170)AtriCure, Inc.2023-10-26
Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) (K221358)AtriCure, Inc.2022-12-30
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (K210477)AtriCure, Inc.2021-07-26
AtriCure Isolator® Synergy™ Surgical Ablation System (K211311)AtriCure, Inc.2021-05-28
AtriClip LAA Exclusion System (K210293)AtriCure, Inc.2021-03-03
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (K200697)AtriCure, Inc.2020-12-23
EPi-Sense Guided Coagulation System with VisiTrax (K193162)AtriCure, Inc.2019-12-13
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (K192125)AtriCure, Inc.2019-11-04
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (K191413)AtriCure, Inc.2019-08-21
Coolrail Linear Pen (K190587)AtriCure, Inc.2019-07-24
COBRA Fusion Ablation System (K190151)AtriCure, Inc.2019-02-25
Coolrail Linear Pen (K183065)AtriCure, Inc.2018-12-04
AtriCure cryoICE cryoSPHERE cryoablation probe (K182565)AtriCure, Inc.2018-11-09
ArtiClip LAA Exclusion System (K181474)AtriCure, Inc.2018-06-28
AtriCure cryoICE cryo-ablation probe (CRYO2) (K180138)AtriCure, Inc.2018-02-15
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) (K180137)AtriCure, Inc.2018-02-15
AtriClip FLEX-V (K180010)AtriCure, Inc.2018-01-31
AtriClip LAA Exclusion System with Preloaded PRO·V Clip (K173031)AtriCure, Inc.2017-10-25
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) (K172742)AtriCure, Inc.2017-10-11
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip (K163261)AtriCure, Inc.2017-05-19
Isolator Multifunctional Linear Pen (K163408)AtriCure, Inc.2017-01-03
cryoFORM cryoICE cryoablation probe (K152337)AtriCure, Inc.2016-03-22
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (K160454)AtriCure, Inc.2016-03-18
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip (K153500)AtriCure, Inc.2016-01-27
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (K150996)AtriCure, Inc.2015-06-17
Atricure Cryo Module System; cryoICE cryoablation probe (K142203)AtriCure, Inc.2014-11-25
cryoICE croablation probe (K142441)AtriCure, Inc.2014-10-29
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP (K142120)AtriCure, Inc.2014-08-28
ATRICURE CRYO MODULE SYSTEM (K140058)AtriCure, Inc.2014-01-24
ATRICLIP GILLINOV-COSGROVE LAA CLIP (K131107)AtriCure, Inc.2013-05-14
ISOLATOR LINEAR PEN (K130521)AtriCure, Inc.2013-04-05
COOLRAIL LINEAR PEN MODEL MCRI (K122611)AtriCure, Inc.2012-09-26
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP (K122276)AtriCure, Inc.2012-08-29
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) (K121507)AtriCure, Inc.2012-06-06
ATRICURE CRYO MODULE SYSTEM (K112072)AtriCure, Inc.2011-08-03
ATRICURE DISSECTOR (K111020)AtriCure, Inc.2011-06-09
ATRICURE CRYO MODULE (K111042)AtriCure, Inc.2011-05-26
ATRICURE BIPOLAR SYSTEM (K110117)AtriCure, Inc.2011-04-08
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 (K101174)AtriCure, Inc.2010-11-12
MULTIFUNCTIONAL LINEAR PEN (K100501)AtriCure, Inc.2010-06-18
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 (K093679)AtriCure, Inc.2010-06-10
ATRICURE CRYO1 CRYO-ABLATION PROBE (K082074)AtriCure, Inc.2009-03-02
ATRICURE COOLRAIL LINEAR PEN (K073605)AtriCure, Inc.2008-03-11
ATRICURE BIPOLAR SYSTEM (K043579)AtriCure, Inc.2007-07-05
ATRICURE ABLATION SYSTEM (K063630)AtriCure, Inc.2007-01-26
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 (K061593)AtriCure, Inc.2006-07-12
ATRICURE TRANSPOLAR SYSTEM (K052893)AtriCure, Inc.2005-10-25
ATRICURE ISOLATOR TRANSPOLAR PEN (K050459)AtriCure, Inc.2005-06-13
ATRICURE DISSECTOR (K041681)AtriCure, Inc.2004-07-01
ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (K020919)AtriCure, Inc.2002-04-19
ATRICURE BIPOLAR COAGULATION SYSTEM (K011722)AtriCure, Inc.2001-08-30

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Every clearance here is in the API, with alerts when new ones post.