FDA.reportPublic FDA data

ATRICURE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30117061103011706110ATRICURE, INC.1N2026-01-017555 Innovation Way Mason OH US 45040
30117887693011788769AtriCure - Minneapolis1N2026-01-01130 Cheshire Ln Ste 250 Minnetonka MN US 55305
30209547463020954746AtriCure, Inc.1N2026-01-013875 Hopyard Rd. Suite 160 Pleasanton CA US 94588

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10840143902666cryoICE® System - Medical Vacuum Connector DISS by 1/4" MNPT866-449-2342SEhlert@atricure.com
10840143902673cryoICE® System - Medical Vacuum Connector Chemetron by 1/4" MNPT866-449-2342SEhlert@atricure.com
10840143902680cryoICE® System - Medical Vacuum Connector PB by 1/4" MNPT866-449-2342SEhlert@atricure.com
10840143902697cryoICE® System - Medical Vacuum Connector Ohmeda by 1/4" MNPT866-449-2342SEhlert@atricure.com
10840143902703cryoICE® System - WAGD Connector DISS by 1/4" MNPT866-449-2342SEhlert@atricure.com
10840143902710cryoICE® System - WAGD Connector Chemetron by 1/4" MNPT866-449-2342SEhlert@atricure.com
10840143902727cryoICE® System - WAGD Connector PB by 1/4" MNPT866-449-2342SEhlert@atricure.com
10840143902734cryoICE® System - WAGD Connector Ohmeda by 1/4" MNPT866-449-2342SEhlert@atricure.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1924391092839684P200002EPi-Sense Guided Coagulation SystemOCM2021-04-28
1924391999481591P100046ATRICURE SYNERGY ABLATION SYSTEMOCM2011-12-14
1924391354916082K811390CCS100 CRYOSURGICAL SYSTEMGEH1981-06-16
1924391621062173K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL2025-07-24
1924391280737425K250371cryoICE cryoXT cryoablation probe (cryoXT)GXH2025-04-10
1924392057222836K243860AtriClip PRO-Mini LAA Exclusion System (PROM)PZX2025-01-15
1924391432684832K243157AtriCure cryoICE BOX (ACM)GXH2024-10-29
1924391427252099K234151Isolator Synergy EnCapture Ablation System (EMH)OCL2024-08-27
1924391877550262K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX2024-07-29
2991151261103081K233959EPi-Ease Epicardial Access Device (EAS)DYB2024-02-13
1924391254379355K233407AtriClip 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)PZX2023-11-02
1924391318544163K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)GXH2023-10-26
1924391114937658K221358Isolator® 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)OCL2022-12-30
1924391875659283K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemOCL2021-05-28
1924391376822867K210293AtriClip LAA Exclusion SystemPZX2021-03-03
1924391381356011K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)GXH2020-12-23
1924391566061938K193162EPi-Sense Guided Coagulation System with VisiTraxOCL2019-12-13
1924391657256391K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenOCL2019-11-04
1924391195333120K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-ClipPZX2019-08-21
1924391997834872K190587Coolrail Linear PenOCL2019-07-24
1924391812961131K190151COBRA Fusion Ablation SystemOCL2019-02-25
1924391147131944K183065Coolrail Linear PenOCL2018-12-04
1924391607874945K182565AtriCure cryoICE cryoSPHERE cryoablation probeGXH2018-11-09
1924392011939813K181474ArtiClip LAA Exclusion SystemPZX2018-06-28
1924391460496404K180138AtriCure cryoICE cryo-ablation probe (CRYO2)GXH2018-02-15
1924391439625973K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)GEH2018-02-15
1924391696388398K180010AtriClip FLEX-VFZP2018-01-31
1924391590053060K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipFZP2016-03-18
1924391464575003K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipFZP2016-01-27
2991151234687945K153096LARIAT RS Suture Delivery DeviceGAT2015-11-25
1924391234687945K153096LARIAT RS Suture Delivery DeviceGAT2015-11-25
1976901727104522K152337cryoFORM cryoICE cryoablation probeGEH2016-03-22
1924391727104522K152337cryoFORM cryoICE cryoablation probeGEH2016-03-22
1976901689357219K142441cryoICE croablation probeGEH2014-10-29
1924391689357219K142441cryoICE croablation probeGEH2014-10-29
1924391428898645K142241LARIAT sulture Delivery DeviceGAT2014-09-12
2991151428898645K142241LARIAT sulture Delivery DeviceGAT2014-09-12
1924391203209798K142203Atricure Cryo Module System; cryoICE cryoablation probeGXH2014-11-25
1924391263229704K142120ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIPFZP2014-08-28
1924392062872636K142084EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXOCL2014-10-28
1924391663986092K131107ATRICLIP GILLINOV-COSGROVE LAA CLIPFZP2013-05-14
1924391878697629K130521ISOLATOR LINEAR PENOCL2013-04-05
1924391908750674K122611COOLRAIL LINEAR PEN MODEL MCRIOCL2012-09-26
1924391183281660K122276ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIPFZP2012-08-29
1924391072841838K120857EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXOCL2012-11-13
1924391013113244K113475ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEMOCL2012-03-20
1924391571036160K111042ATRICURE CRYO MODULEGEH2011-05-26
1924391962866749K111020ATRICURE DISSECTORFTD2011-06-09
1924391029007895K110117ATRICURE BIPOLAR SYSTEMOCL2011-04-08
1924391987642397K101174ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2OCL2010-11-12
1924391100224509K093679ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0FZP2010-06-10
2991152055779782K090385LARIAT II SUTURE DELIVERY DEVICEGAT2009-05-06
1924392055779782K090385LARIAT II SUTURE DELIVERY DEVICEGAT2009-05-06
1924391451304445K090202NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125OCL2009-02-17
1924391090430496K082203NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025OCL2008-12-30
2991151544752783K080364FINDRWIRZ GUIDE WIRE SYSTEMDQX2008-08-11
1924391544752783K080364FINDRWIRZ GUIDE WIRE SYSTEMDQX2008-08-11
2991151738849252K070126OCCLUSION BALLOON CATHETERDQY2008-02-08
1924391738849252K070126OCCLUSION BALLOON CATHETERDQY2008-02-08
1924391747088737K063630ATRICURE ABLATION SYSTEMGEI2007-01-26
1924391989917018K061593ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1OCL2006-07-12
1924392052862137K053326ESTECH COBRA ELECTROSURGICAL UNIT & CABLEGEI2006-01-06
1924391950973160K041599COBRA ADHERE SURGICAL SYSTEMGEI2004-07-27
1924391333753607
1924391231236759
1924391251053735
1924391356122521
2991151356122521
1924391455804686
1924391651111601
2991151651111601
1924392007943527

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCL192025-07-24
GXH72025-04-10
GEH72018-02-15
FZP72018-01-31
PZX62025-01-15
GAT62015-11-25
GEI32007-01-26
DQX22008-08-11
DQY22008-02-08
DYB12024-02-13
OCM 12021-04-28
OCM12011-12-14
FTD12011-06-09

PMA#

EPi-Sense®, EPi-Sense ST™ Guided Coagulation System

2022-12-27

AtriCure, Inc.7555 Innovation Waywest Chester, OH 45040 PMA NumberP200002 Supplement NumberS004 Date Received09/28/2022 Decision Date12/27/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change ...

AtriCure Synergy Ablation System

2022-11-15

ATRICURE INC.7555 Innovation Waymason, OH 45040 PMA NumberP100046 Supplement NumberS013 Date Received03/01/2022 Decision Date11/15/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/c...

EPi-Sense® ST Guided Coagulation System

2022-08-16

AtriCure, Inc.7555 Innovation Waywest Chester, OH 45040 PMA NumberP200002 Supplement NumberS002 Date Received02/17/2022 Decision Date08/16/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change ...

PMN#

58 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next