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 |
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 |
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 |