Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue2Product Code
- K234151Isolator Synergy EnCapture Ablation System (EMH)2Cleared 510(K)
- K221358Isolator® 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)2Cleared 510(K)
- K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device2Cleared 510(K)
- K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE2Cleared 510(K)
- K211311AtriCure Isolator® Synergy™ Surgical Ablation System2Cleared 510(K)
- K200514Cardioblate Gemini-s Surgical Ablation Device2Cleared 510(K)
- K193162EPi-Sense Guided Coagulation System with VisiTrax2Cleared 510(K)
- K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen2Cleared 510(K)
- K191526Cardioblate CryoFlex Surgical Ablation System2Cleared 510(K)
- K190587Coolrail Linear Pen2Cleared 510(K)
- K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device2Cleared 510(K)
- K190151COBRA Fusion Ablation System2Cleared 510(K)
- K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device2Cleared 510(K)
- K183065Coolrail Linear Pen2Cleared 510(K)
- K163408Isolator Multifunctional Linear Pen2Cleared 510(K)
- K142084EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX2Cleared 510(K)
- K130521ISOLATOR LINEAR PEN2Cleared 510(K)
- K123733CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM2Cleared 510(K)
- K120857EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX2Cleared 510(K)
- K121878CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES2Cleared 510(K)
- K122611COOLRAIL LINEAR PEN MODEL MCRI2Cleared 510(K)
- K121767CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE2Cleared 510(K)
- K121451CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE2Cleared 510(K)
- K113475ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM2Cleared 510(K)
- K110913ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY2Cleared 510(K)
- K110117ATRICURE BIPOLAR SYSTEM2Cleared 510(K)
- K101174ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML22Cleared 510(K)
- K100501MULTIFUNCTIONAL LINEAR PEN2Cleared 510(K)
- K090721CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 492052Cleared 510(K)
- K090202NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -1252Cleared 510(K)
- K082203NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-0252Cleared 510(K)
- K082279EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-22Cleared 510(K)
- K080292EPICOR ABLATION SYSTEM2Cleared 510(K)
- K080509CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE2Cleared 510(K)
- K073605ATRICURE COOLRAIL LINEAR PEN2Cleared 510(K)
- K071819NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-5152Cleared 510(K)
- K043579ATRICURE BIPOLAR SYSTEM2Cleared 510(K)
- K070288CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 608142Cleared 510(K)
- K063012NCONTACT COAGULATION SYSTEM KIT, MODEL CSK2Cleared 510(K)
- K062140SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS12Cleared 510(K)
- K061593ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB12Cleared 510(K)
- K060715MODIFICATION TO: CARDIMA ABLATION SYSTEM2Cleared 510(K)
- K053436SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE2Cleared 510(K)
- K050459ATRICURE ISOLATOR TRANSPOLAR PEN2Cleared 510(K)
- K041890CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-122Cleared 510(K)
- K040690SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE2Cleared 510(K)
- K022008CARDIMA ABLATION SYSTEM2Cleared 510(K)
- K021010MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE2Cleared 510(K)
- K013392CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 608802Cleared 510(K)
- K011988SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C2Cleared 510(K)
- K011040CRYOCARE CARDIAC SURGICAL SYSTEM2Cleared 510(K)
- K974320CRYOGEN CARDIAC CRYOSURGICAL SYSTEM2Cleared 510(K)
- K970496HEARTPORT MAZE SYSTEM: CRYOPROBE SET2Cleared 510(K)
- PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement2Product Code
- PZXLeft Atrial Appendage Clip, Implantable2Product Code
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K190623
- 510(k) Type
- Traditional
- Applicant
- Medtronic
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/30/2019
- Days to Decision
- 80 days
- Submission Type
- Summary