FDA 510(k) Applications for Medical Device Product Code "DRF"
(Catheter, Electrode Recording, Or Probe, Electrode Recording)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K192037 | Abbott Medical | Advisor VL Circular Mapping Catheter, Sensor Enabled | 09/17/2019 |
| K160390 | ACCESS POINT TECHNOLOGIES EP, INC. | Map-it Diagnostic Mapping Catheters | 04/11/2016 |
| K042105 | BARD ELECTROPHYSIOLOGY | CLIPPER DIAGNOSTIC ELECTRODE CATHETER | 09/23/2004 |
| K183649 | Baylis Medical Company Inc. | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | 06/07/2019 |
| K183632 | Baylis Medical Company Inc. | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | 06/07/2019 |
| K002333 | BIOSENSE WEBSTER, INC. | BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 | 08/31/2000 |
| K060047 | BIOSENSE WEBSTER, INC. | CARTO RMT EP NAVIGATION SYSTEM V8 | 06/19/2006 |
| K050877 | BIOSENSE WEBSTER, INC. | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR | 06/24/2005 |
| K090898 | BIOSENSE WEBSTER, INC. | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER | 09/04/2009 |
| K080425 | BIOSENSE WEBSTER, INC. | CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 | 04/23/2008 |
| K061463 | BIOSENSE WEBSTER, INC. | ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S | 08/14/2006 |
| K113213 | BIOSENSE WEBSTER, INC. | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | 12/05/2011 |
| K093376 | BIOSENSE WEBSTER, INC. | LASSO NAV CATHETER | 06/18/2010 |
| K130602 | BIOSENSE WEBSTER, INC. | LASSO NAV DUO LOOP CATHETER | 08/14/2013 |
| K193632 | Biosense Webster, Inc. | LassoStar Circular Mapping Catheter | 06/30/2020 |
| K211219 | Biosense Webster, Inc. | LASSOSTAR NAV Circular Mapping Catheter | 01/26/2022 |
| K052083 | BIOSENSE WEBSTER, INC. | NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER | 09/29/2005 |
| K061468 | BIOSENSE WEBSTER, INC. | REFSTAR EXTERNAL REFERENCE PATCH | 08/14/2006 |
| K090120 | BIOSENSE WEBSTER, INC. | REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 | 03/24/2009 |
| K042998 | BIOSENSE WEBSTER, INC. | REFSTAR RMT EXTERNAL REFERENCE PATCH | 09/29/2005 |
| K031161 | BIOSENSE WEBSTER, INC. | VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER | 07/22/2003 |
| K081258 | BIOSENSE WEBSTER, INC. | VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 | 01/06/2009 |
| K101345 | BIOSENSE WEBSTER, INC. | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, | 06/22/2010 |
| K101991 | BIOSENSE WEBSTER, INC. | WEBSTER DUO-DECAPOLAR CATHETER | 05/02/2011 |
| K960542 | BIOSENSE, LTD. | NOGA | 04/15/1996 |
| K212593 | Biotronick, Inc. | ViaCath, AcQRate Dx Steerable Catheter | 10/15/2021 |
| K201445 | Biotronik, Inc | MultiCath, AcQRate Dx Fixed Curve Catheter | 09/02/2021 |
| K230503 | Boston Scientific | Polaris XÖ Catheter Cable, BlazerÖ Dx-20 Catheter Cable | 04/25/2023 |
| K081576 | BOSTON SCIENTIFIC CORP. | BLAZER DX-20 DIAGNOSTIC CATHETER | 02/03/2009 |
| K953750 | BOSTON SCIENTIFIC CORP. | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 03/11/1996 |
| K954651 | BOSTON SCIENTIFIC CORP. | ELECTRODE RECORDING CATHETER | 10/22/1996 |
| K211375 | Boston Scientific Corporation | BlazerÖ Dx-20 Bidirectional Steerable Diagnostic Catheter | 09/10/2021 |
| K232651 | Boston Scientific Corporation | BLAZERÖ Dx-20 Bidirectional Steerable Diagnostic Catheter | 09/29/2023 |
| K220796 | Boston Scientific Corporation | IntellaMap Orion High Resolution Mapping Catheter | 06/10/2022 |
| K192360 | Boston Scientific Corporation | IntellaMap Orion High Resolution Mapping Catheter | 10/25/2019 |
| K211494 | Boston Scientific Corporation | Polaris X Unidirectional Steerable Diagnostic Catheter | 09/14/2021 |
| K030627 | C.R. BARD, INC. | ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 | 10/23/2003 |
| K992373 | C.R. BARD, INC. | ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE | 11/05/1999 |
| K091370 | C.R. BARD, INC. | RADIA STEERABLE DIAGNOSTIC CATHETER | 06/05/2009 |
| K971265 | C.R. BARD, INC. | VIKING DIAGNOSTIC ELECTRODE CATHETER | 10/23/1997 |
| K955847 | CARDIAC ASSIST DEVICES, INC. | GYRO TIP EP CATHETER | 01/29/1997 |
| K012520 | CARDIAC ASSIST DEVICES, INC. | GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E | 03/27/2002 |
| K965066 | CARDIAC PATHWAYS CORP. | ARRHYTHMIA MAPPING SYSTEM (8100/8300) | 08/11/1997 |
| K992912 | CARDIAC PATHWAYS CORP. | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH | 03/08/2000 |
| K983653 | CARDIAC PATHWAYS CORP. | RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D | 12/22/1998 |
| K971975 | CARDIMA, INC. | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER | 07/01/1998 |
| K982835 | CARDIMA, INC. | ELECTRODE SWITCHBOX, MODEL 11-081002 | 10/29/1998 |
| K955802 | CARDIMA, INC. | PATHFINDER | 01/29/1997 |
| K970853 | CARDIMA, INC. | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) | 11/04/1997 |
| K972803 | CARDIMA, INC. | TRACER O-T-W MAPPING DEVICE | 05/11/1999 |
| K011361 | CATHEFFECTS, LLC. | DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE | 09/06/2001 |
| K211327 | CathRxLtd | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters | 02/10/2022 |
| K000753 | CORDIS CORP. | CORDIS 13F CATHETER SHEATH INTRODUCER | 04/06/2000 |
| K991531 | CORDIS WEBSTER, INC. | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | 10/04/1999 |
| K992965 | CORDIS WEBSTER, INC. | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | 11/26/1999 |
| K980961 | CORDIS WEBSTER, INC. | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | 05/28/1998 |
| K982415 | CORDIS WEBSTER, INC. | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | 08/10/1998 |
| K953663 | CORDIS WEBSTER, INC. | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | 09/18/1996 |
| K955817 | CORDIS WEBSTER, INC. | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | 03/25/1996 |
| K991001 | EP MEDSYSTEMS | MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | 07/15/1999 |
| K984150 | EP MEDSYSTEMS | PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | 02/22/1999 |
| K033963 | EP MEDSYSTEMS, INC. | EP DEFLECTABLE CATHETERS | 04/15/2004 |
| K003452 | EP TECHNOLOGIES, INC. | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D | 12/07/2000 |
| K043257 | EP TECHNOLOGIES, INC. | REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM | 02/03/2005 |
| K962307 | FIDUS MEDICAL TECHNOLOGY CORP. | RHYDER DIAGNOSTIC CATHETER | 09/17/1996 |
| K963074 | HARMAC MEDICAL PRODUCTS, INC. | HARMAC QUADPOLAR MAPPING PACING CATHETER | 06/25/1997 |
| K191880 | Innovative Health, LLC. | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | 12/11/2019 |
| K203261 | Innovative Health, LLC. | Reprocessed Inquiry Steerable Diagnostic EP Catheter | 03/05/2021 |
| K171277 | Innovative Health, LLC. | Reprocessed Inquiry Steerable Diagnostic EP Catheter | 10/23/2017 |
| K182386 | Innovative Health, LLC. | Reprocessed Supreme Diagnostic Electrophysiology Catheter | 04/23/2019 |
| K161769 | INNOVATIVE HEALTH, LLC. | Reprocessed Supreme Diagnostic Electrophysiology Catheters | 12/06/2016 |
| K190980 | Innovative Health, LLC. | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | 07/01/2019 |
| K010471 | IRVINE BIOMEDICAL, INC. | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 | 06/06/2001 |
| K961924 | IRVINE BIOMEDICAL, INC. | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | 04/11/1997 |
| K053582 | IRVINE BIOMEDICAL, INC. | INQUIRY AFOCUS II DIAGNOSTIC CATHETER | 03/21/2006 |
| K042775 | IRVINE BIOMEDICAL, INC. | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER | 11/04/2004 |
| K082061 | IRVINE BIOMEDICAL, INC. | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER | 08/19/2008 |
| K060757 | IRVINE BIOMEDICAL, INC. | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER | 04/19/2006 |
| K991025 | IRVINE BIOMEDICAL, INC. | LUMA-CATH FIXED CURVE EP CATHETERS | 10/15/1999 |
| K991878 | IRVINE BIOMEDICAL, INC. | LUMA-CATH STEERABLE EP CATHETERS | 12/10/1999 |
| K982232 | IRVINE BIOMEDICAL, INC. | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | 07/25/1998 |
| K990958 | IRVINE BIOMEDICAL, INC. | ORTHOGONAL EP CATHETERS | 06/03/1999 |
| K973639 | J-LLOYD MEDICAL, INC. | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. | 04/20/1998 |
| K971504 | J-LLOYD MEDICAL, INC. | HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER | 04/20/1998 |
| K151139 | MedFact Engineering GmbH | EasyMap MAP Catheter | 10/18/2016 |
| K183547 | Medtronic | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | 07/30/2019 |
| K190132 | Medtronic | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | 07/30/2019 |
| K102588 | MEDTRONIC ABLATION FRONTIERS, LLC | ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE | 03/18/2011 |
| K964272 | MEDTRONIC CARDIORHYTHM | PERFORMR SERIES EP DIAGNOSTIC CATHETERS | 01/23/1997 |
| K953185 | MEDTRONIC CARDIORHYTHM | PLATINUM SERIES EP DIAGNOSTIC CATHETERS | 04/15/1996 |
| K981642 | MEDTRONIC CARDIORHYTHM | STABLEMAPR STEERABLE INTRACARDIAC CATHETERS | 08/05/1998 |
| K162892 | MEDTRONIC INC. | Achieve Advance Mapping Catheter | 11/15/2016 |
| K033050 | MEDTRONIC VASCULAR | EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 | 03/26/2004 |
| K153139 | MEDTRONIC, INC. | Achieve ST Mapping Catheter, Catheter Connecting Cable | 05/06/2016 |
| K030852 | MOGUL ENTERPRISES | 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX | 07/10/2003 |
| K011734 | MOGUL ENTERPRISES | 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX | 07/03/2001 |
| K993698 | MOGUL ENTERPRISES | SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX | 08/16/2000 |
| K061678 | PRORHYTHM | PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 | 01/12/2007 |
| K143481 | RHYTHMIA MEDICAL, INC | IntellaMap Orion High Resolution Mapping Catheter | 01/08/2015 |
| K122461 | RHYTHMIA MEDICAL, INC | RHYTHMIA MAPPING CATHETER | 04/18/2013 |
| K210313 | Shanghai MicroPort EP MedTech Co., Ltd. | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | 12/30/2022 |
| K011766 | ST. JUDE MEDICAL | 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 | 07/03/2001 |
| K160335 | St. Jude Medical | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D | 12/13/2016 |
| K101623 | ST. JUDE MEDICAL | INQUIRY AFOCUSII DIAGNOSTIC CATHETER | 08/13/2010 |
| K022380 | ST. JUDE MEDICAL | LIVESIRE ELECTROPHYSIOLOGY CATHETER | 10/01/2002 |
| K102721 | ST. JUDE MEDICAL | LIVEWIRE ELECTOPHYSIOLOGY CATHETER | 10/18/2010 |
| K080179 | ST. JUDE MEDICAL | REFLEXION HD HIGH-DENSITY MAPPING CATHETER | 01/07/2009 |
| K072012 | ST. JUDE MEDICAL | REFLEXION SPIRAL VARIABLE RADIUS CATHETER | 08/22/2007 |
| K062251 | ST. JUDE MEDICAL | REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 | 10/20/2006 |
| K002976 | ST. JUDE MEDICAL | RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX | 12/22/2000 |
| K120544 | ST. JUDE MEDICAL | RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN | 03/19/2012 |
| K101955 | ST. JUDE MEDICAL | ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 | 10/15/2010 |
| K081803 | ST. JUDE MEDICAL | ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM | 05/13/2009 |
| K150631 | St. Jude Medical | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter | 04/01/2015 |
| K151622 | St. Jude Medical | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electroph | 07/15/2015 |
| K013484 | STEREOTAXIS, INC. | TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH | 05/02/2002 |
| K203793 | Synaptic Medical Corporation | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | 02/14/2022 |
| K133028 | SYNAPTIC MEDICAL LIMITED | RITHM ID ELECTROPHYSIOLOGY CATHETER | 03/04/2014 |
| K021421 | TZ MEDICAL, INC. | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE | 04/18/2003 |
| K991060 | ZCV ,INC. | ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 | 04/06/2000 |
| K011847 | ZYNERGY CARDIO VASULAR (ZCV), INC. | ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE | 07/13/2001 |
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