Current Marketed Products and FDA Clearance information Tradename AtriCure Product Codes ACC2 Cardiac Cryosurgical System (includes probes) ACC2, 3011, 3015, 3004, 3014 Wolf Lumpitip Dissector Isolator Transpolar Pen AtriCure Ablation System Coolrail linear pen cryoICE cryo-ablation probe* MID1, GPD1* MAX1, MAX5, ASU2, ASB1 OLL2, OSL2, EMR2, EML2, ASU2, ASB3 MCR1 CRYO2* AtriCure AtriClip LAA LAA035, LAA040, Exclusion System with LAA045, LAA050, preloaded Gillinov-Cosgrove ACH135*, ACH140*, Clip ACH145*, ACH150* Multifunctional linear pen AtriCure Bipolar System Isolator Synergy Access clamp AtriCure Cryo Module System AtriCure Synergy Ablation System AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip Type of Submission Date Cleared FDA Document Number 510(k) 6/16/1981 K811390 The ACC2 Cardiac Cryosurgical System is intended for use in the cyrosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflamatory response (cryonecrosis) that blocks the electrical conduction pathway. 510(k) 7/1/2004 12/7/2006* 6/9/2011 K041681 *LTF K111020 The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector’s battery-powered light source is used to navigate soft tissue for identification of anatomic structures. 510(k) 6/10/2005, 7/12/2006 K050459, K061593 510(k) 1/26/2007 K063630 510(k) 3/11/2008 9/26/2012 K073605 K122611 The Isolator Transpolar Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. The AtriCure Ablation System is intended to ablate soft tissues during general surgery using radiofrequency energy. The Coolrail™ linear pen is a sterile, single use, electrosurgical device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. 510(k) 3/2/2009 10/14/2010* K082074 *LTF The CryoICE cryoablation probe is a sterile, single use device intended to use in the cyrosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflamatory response (cryonecrosis) that blocks the electrical conduction pathway. K093679 *LTF The AtriClip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial as well as thoracotomy (single or multiple). 510(k) 6/10/2010 7/28/2010* MLP1 OLL2, OSL2, EMR2, EML2, ASU2, ASB3 510(k) 6/18/2010 4/5/2013 K100501 K130521 510(k) 11/12/2010 K101174 EMT1 510(k) 4/8/2011 K110117 The Multifunctional Linear Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the AtriCure Ablation and Sensing unit (ASU) or to the ASU Source Switch in Ablation mode. The Multifunctional Linear Pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery. The AtriCure Bipolar System is intended for the ablation of cardiac tissue during surgery. 510(k) 5/26/2011 8/3/2011 6/6/2012 1/24/2014 K111042 K112072 K121507 K140058 The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)—a non-sterile, reusable device—used with the Cryo1 cryo-ablation probe—a sterile, single use device—and/or the cryoICE cryo-ablation probe—a sterile, single use device. P100046 The AtriCure Synergy Ablation System is indicated for the ablation of cardiac tissue for the treatment of persistent atrial fibrillation (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion) or longstanding persistent atrial fibrillation (continuous atrial fibrillation of greater than on year duration) in patients who are undergoing open concomitant coronary artery bypass grafting and/or valve replacement or repair. K122276 The AtriClip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial as well as thoracotomy (single or multiple). K131107 N/A class I device N/A class I device The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial as well as thoracotomy (single or multiple). The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The AtriCure Instrumemt Guide is a sterile, disposable device for use in general surgical procedures. ACM1, CRYO1, CRYO2 OLL2, OSL2, ASU2, ASB3 PRO135, PRO140, PRO145, PRO150 PMA 510(k) 12/14/2011 8/29/2012 AtriClip Gillinov-Cosgrove LAA Clip CGC135, CGC140, CGC145, CGC150 Reusable Clip Applier RCA GPT100, GPT200, GPT300 N/A class I device N/A class I device 5/14/2013 N/A class I device N/A class I device ASC N/A class I device N/A class I device N/A class I device CGG1 N/A class I device N/A class I device N/A class I device Glidepath Tape Compact Cart Gillinov-Cosgrove Selection Guide Indication 510(k) The AtriCure System Cart is intended to be used as an accessory to the AtriCure Bipolar System, AtriCure Cryo Module System, and ORLab. The AtriClip® Gillinov-Cosgrove™ Selection Guide (Guide) is intended to be used as an accessory to the AtriClip® LAA Exclusion System with preloaded Gillinov-Cosgrove™ Clip (Clip). 2/10/2014