FDA 510(k) Applications for Medical Device Product Code "OCL"
(Surgical Device, For Ablation Of Cardiac Tissue)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K210477 | AtriCure Inc. | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | 07/26/2021 |
| K163408 | AtriCure Inc. | Isolator Multifunctional Linear Pen | 01/03/2017 |
| K234151 | AtriCure Inc. | Isolator Synergy EnCapture Ablation System (EMH) | 08/27/2024 |
| K190587 | AtriCure, Inc | Coolrail Linear Pen | 07/24/2019 |
| K192125 | AtriCure, Inc | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | 11/04/2019 |
| K221358 | AtriCure, Inc | Isolator« Linear Pen (MLP1); Isolator« TranspolarÖ Pen (MAX1, MAX5), Coolrail« Linear Pen (MCR1); Isolator« Synergy Surgical Ablation System (EMR2, EML2); Isolator« SynergyÖ EnCompass Clamp (OLH, OSH) and Guide System; Isolator« Synergy Access Clamp (EMT1 | 12/30/2022 |
| K043579 | ATRICURE, INC. | ATRICURE BIPOLAR SYSTEM | 07/05/2007 |
| K110117 | ATRICURE, INC. | ATRICURE BIPOLAR SYSTEM | 04/08/2011 |
| K101174 | ATRICURE, INC. | ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 | 11/12/2010 |
| K073605 | ATRICURE, INC. | ATRICURE COOLRAIL LINEAR PEN | 03/11/2008 |
| K050459 | ATRICURE, INC. | ATRICURE ISOLATOR TRANSPOLAR PEN | 06/13/2005 |
| K061593 | ATRICURE, INC. | ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 | 07/12/2006 |
| K211311 | AtriCure, Inc. | AtriCure Isolator« SynergyÖ Surgical Ablation System | 05/28/2021 |
| K190151 | AtriCure, Inc. | COBRA Fusion Ablation System | 02/25/2019 |
| K183065 | AtriCure, Inc. | Coolrail Linear Pen | 12/04/2018 |
| K122611 | ATRICURE, INC. | COOLRAIL LINEAR PEN MODEL MCRI | 09/26/2012 |
| K193162 | AtriCure, Inc. | EPi-Sense Guided Coagulation System with VisiTrax | 12/13/2019 |
| K130521 | ATRICURE, INC. | ISOLATOR LINEAR PEN | 04/05/2013 |
| K252056 | AtriCure, Inc. | Isolator« SynergyÖ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | 07/24/2025 |
| K100501 | ATRICURE, INC. | MULTIFUNCTIONAL LINEAR PEN | 06/18/2010 |
| K022008 | CARDIMA, INC. | CARDIMA ABLATION SYSTEM | 01/29/2003 |
| K060715 | CARDIMA, INC. | MODIFICATION TO: CARDIMA ABLATION SYSTEM | 05/15/2006 |
| K011988 | CARDIOFOCUS, INC. | SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C | 09/20/2001 |
| K040690 | CRYOCATH TECHNOLOGIES, INC. | SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE | 04/29/2004 |
| K053436 | CRYOCATH TECHNOLOGIES, INC. | SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE | 01/13/2006 |
| K062140 | CRYOCATH TECHNOLOGIES, INC. | SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 | 08/24/2006 |
| K041890 | CRYOCOR, INC. | CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 | 09/22/2004 |
| K974320 | CRYOGEN, INC. | CRYOGEN CARDIAC CRYOSURGICAL SYSTEM | 02/03/1998 |
| K011040 | ENDOCARE, INC. | CRYOCARE CARDIAC SURGICAL SYSTEM | 06/15/2001 |
| K021010 | ENDOCARE, INC. | MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE | 06/06/2002 |
| K113475 | ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM | 03/20/2012 |
| K110913 | ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH | ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY | 09/23/2011 |
| K970496 | HEARTPORT, INC. | HEARTPORT MAZE SYSTEM: CRYOPROBE SET | 05/09/1997 |
| K200514 | Medtronic | Cardioblate Gemini-s Surgical Ablation Device | 06/03/2020 |
| K090721 | Medtronic | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 | 06/16/2009 |
| K190623 | Medtronic | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | 05/30/2019 |
| K182610 | Medtronic | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | 12/19/2018 |
| K080509 | MEDTRONIC INC. | CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE | 05/05/2008 |
| K121878 | MEDTRONIC INC. | CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES | 11/02/2012 |
| K123733 | MEDTRONIC INC. | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM | 04/01/2013 |
| K121767 | MEDTRONIC INC. | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE | 07/13/2012 |
| K223508 | Medtronic Inc. | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | 12/22/2022 |
| K121451 | MEDTRONIC INC. | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE | 06/14/2012 |
| K070288 | MEDTRONIC VASCULAR | CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 | 06/18/2007 |
| K013392 | MEDTRONIC VASCULAR | CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 | 01/25/2002 |
| K191526 | Medtronic, Inc. | Cardioblate CryoFlex Surgical Ablation System | 10/01/2019 |
| K120857 | NCONTACT SURGICAL, INC. | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | 11/13/2012 |
| K142084 | NCONTACT SURGICAL, INC. | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | 10/28/2014 |
| K063012 | NCONTACT SURGICAL, INC. | NCONTACT COAGULATION SYSTEM KIT, MODEL CSK | 12/01/2006 |
| K071819 | NCONTACT SURGICAL, INC. | NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 | 07/26/2007 |
| K082203 | NCONTACT SURGICAL, INC. | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 | 12/30/2008 |
| K090202 | NCONTACT SURGICAL, INC. | NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 | 02/17/2009 |
| K082279 | ST. JUDE MEDICAL | EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 | 09/16/2008 |
| K080292 | ST. JUDE MEDICAL | EPICOR ABLATION SYSTEM | 07/25/2008 |
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