Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

FDA product code OCL · 53 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4400
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1997-05-09 – 2025-07-24

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

OCL 2025-07-24

Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)

Applicant AtriCure, Inc.

K number K252056

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OCL 2024-08-27

Isolator Synergy EnCapture Ablation System (EMH)

Applicant AtriCure, Inc.

K number K234151

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OCL 2022-12-30

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)

Applicant AtriCure, Inc.

K number K221358

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OCL 2022-12-22

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

Applicant Medtronic, Inc.

K number K223508

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OCL 2021-07-26

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

Applicant AtriCure, Inc.

K number K210477

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OCL 2021-05-28

AtriCure Isolator® Synergy™ Surgical Ablation System

Applicant AtriCure, Inc.

K number K211311

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OCL 2020-06-03

Cardioblate Gemini-s Surgical Ablation Device

Applicant Medtronic

K number K200514

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OCL 2019-12-13

EPi-Sense Guided Coagulation System with VisiTrax

Applicant AtriCure, Inc.

K number K193162

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OCL 2019-11-04

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen

Applicant AtriCure, Inc.

K number K192125

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OCL 2019-10-01

Cardioblate CryoFlex Surgical Ablation System

Applicant Medtronic, Inc.

K number K191526

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OCL 2019-07-24

Coolrail Linear Pen

Applicant AtriCure, Inc.

K number K190587

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OCL 2019-05-30

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device

Applicant Medtronic

K number K190623

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OCL 2019-02-25

COBRA Fusion Ablation System

Applicant AtriCure, Inc.

K number K190151

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OCL 2018-12-19

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device

Applicant Medtronic

K number K182610

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OCL 2018-12-04

Coolrail Linear Pen

Applicant AtriCure, Inc.

K number K183065

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OCL 2017-01-03

Isolator Multifunctional Linear Pen

Applicant AtriCure, Inc.

K number K163408

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OCL 2013-04-05

ISOLATOR LINEAR PEN

Applicant AtriCure, Inc.

K number K130521

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OCL 2013-04-01

CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM

Applicant Medtronic, Inc.

K number K123733

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OCL 2012-11-13

EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

Applicant Ncontact Surgical, Inc.

K number K120857

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OCL 2012-11-02

CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES

Applicant Medtronic, Inc.

K number K121878

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OCL 2012-09-26

COOLRAIL LINEAR PEN MODEL MCRI

Applicant AtriCure, Inc.

K number K122611

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OCL 2012-07-13

CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE

Applicant Medtronic, Inc.

K number K121767

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OCL 2012-06-14

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE

Applicant Medtronic, Inc.

K number K121451

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OCL 2012-03-20

ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM

Applicant Endoscopic Technologies, Inc. D/B/A Estech

K number K113475

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OCL 2011-09-23

ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY

Applicant Endoscopic Technologies, Inc. D/B/A Estech

K number K110913

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OCL 2011-04-08

ATRICURE BIPOLAR SYSTEM

Applicant AtriCure, Inc.

K number K110117

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OCL 2010-11-12

ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2

Applicant AtriCure, Inc.

K number K101174

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OCL 2010-06-18

MULTIFUNCTIONAL LINEAR PEN

Applicant AtriCure, Inc.

K number K100501

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OCL 2009-06-16

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205

Applicant Medtronic

K number K090721

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OCL 2009-02-17

NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125

Applicant Ncontact Surgical, Inc.

K number K090202

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OCL 2008-12-30

NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025

Applicant Ncontact Surgical, Inc.

K number K082203

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OCL 2008-09-16

EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2

Applicant St Jude Medical

K number K082279

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OCL 2008-07-25

EPICOR ABLATION SYSTEM

Applicant St Jude Medical

K number K080292

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OCL 2008-05-05

CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE

Applicant Medtronic, Inc.

K number K080509

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OCL 2008-03-11

ATRICURE COOLRAIL LINEAR PEN

Applicant AtriCure, Inc.

K number K073605

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OCL 2007-07-26

NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515

Applicant Ncontact Surgical, Inc.

K number K071819

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OCL 2007-07-05

ATRICURE BIPOLAR SYSTEM

Applicant AtriCure, Inc.

K number K043579

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OCL 2007-06-18

CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814

Applicant Medtronic Vascular

K number K070288

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OCL 2006-12-01

NCONTACT COAGULATION SYSTEM KIT, MODEL CSK

Applicant Ncontact Surgical, Inc.

K number K063012

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OCL 2006-08-24

SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1

Applicant Cryocath Technologies, Inc.

K number K062140

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OCL 2006-07-12

ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1

Applicant AtriCure, Inc.

K number K061593

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OCL 2006-05-15

MODIFICATION TO: CARDIMA ABLATION SYSTEM

Applicant Cardima, Inc.

K number K060715

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OCL 2006-01-13

SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

Applicant Cryocath Technologies, Inc.

K number K053436

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OCL 2005-06-13

ATRICURE ISOLATOR TRANSPOLAR PEN

Applicant AtriCure, Inc.

K number K050459

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OCL 2004-09-22

CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12

Applicant Cryocor, Inc.

K number K041890

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OCL 2004-04-29

SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

Applicant Cryocath Technologies, Inc.

K number K040690

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OCL 2003-01-29

CARDIMA ABLATION SYSTEM

Applicant Cardima, Inc.

K number K022008

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OCL 2002-06-06

MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE

Applicant Endocare, Inc.

K number K021010

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OCL 2002-01-25

CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880

Applicant Medtronic Vascular

K number K013392

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OCL 2001-09-20

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

Applicant Cardiofocus, Inc.

K number K011988

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OCL 2001-06-15

CRYOCARE CARDIAC SURGICAL SYSTEM

Applicant Endocare, Inc.

K number K011040

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OCL 1998-02-03

CRYOGEN CARDIAC CRYOSURGICAL SYSTEM

Applicant Cryogen, Inc.

K number K974320

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OCL 1997-05-09

HEARTPORT MAZE SYSTEM: CRYOPROBE SET

Applicant Heartport, Inc.

K number K970496

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