510kDecisions.com

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
K770709 3M HEALTH CARE, SARNS PROBE, TEMPERATURE, SYSTEM, SARNS 04/27/1977
K915563 ARRHYTHMIA TECHNOLOGIES, INC. DIAGNOSTIC EP CATHETER 03/09/1992
K915640 ARRHYTHMIA TECHNOLOGIES, INC. VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER 03/09/1992
K945229 ARROW INTL., INC. ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS 08/08/1995
K911065 ARROW INTL., INC. ARROW QUADPOLAR MAPPING/PACING CATHETER 06/18/1992
K953651 ARROW INTL., INC. DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM 11/30/1995
K905831 ARZCO MEDICAL ELECTRONICS, INC. ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH 03/29/1991
K903136 ARZCO MEDICAL ELECTRONICS, INC. ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER 01/18/1991
K893611 BARD ELECTROPHYSIOLOGY BARD PLAQUE ELECTRODE ARRAY 07/14/1989
K042105 BARD ELECTROPHYSIOLOGY CLIPPER DIAGNOSTIC ELECTRODE CATHETER 09/23/2004
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
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
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
K924163 BOSTON SCIENTIFIC CORP. EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC 09/03/1993
K951744 BOSTON SCIENTIFIC CORP. LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS 05/04/1995
K873995 C.R. BARD, INC. BARD DESAI CATHETER ELECTRODE 01/07/1988
K872231 C.R. BARD, INC. BARD EPICARDIAL ELECTRODE ARRAY 10/09/1987
K874208 C.R. BARD, INC. BARD OCTAPOLAR ELECTRODE CATHETER 12/29/1987
K911140 C.R. BARD, INC. BARD(R) ENDOCARDIAL BALLOON ARRAY 05/07/1991
K891908 C.R. BARD, INC. BARD(R) TIP DEFLECTING ELECTRODE CATHETER 06/05/1989
K881966 C.R. BARD, INC. ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER 10/04/1988
K902228 C.R. BARD, INC. MODIFIED EPICARDIAL ARRAY 07/06/1990
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
K802058 CARDIAC PACEMAKERS, INC. MAPPING PROBE MODEL #6540 11/19/1980
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
K923915 CARDIORHYTHM TORQR SERIES DIAGNOSTIC EP CATHETERS 02/10/1993
K923916 CARDIORHYTHM VOYAGR SERIES DIAGNOSTIC EP CATHETERS 02/10/1993
K011361 CATHEFFECTS, LLC. DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE 09/06/2001
K000753 CORDIS CORP. CORDIS 13F CATHETER SHEATH INTRODUCER 04/06/2000
K953768 CORDIS WEBSTER, INC. CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER 11/22/1995
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
K954390 CORDIS WEBSTER, INC. CORDIS WESTER STAR CATHETER 12/21/1995
K955817 CORDIS WEBSTER, INC. CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER 03/25/1996
K942379 DAIG CORP. DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER 12/27/1994
K894500 DAIG CORP. DAIG ELECTROPHYSIOLOGY CATHETER 09/18/1989
K914278 DAIG CORP. DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN 03/04/1992
K933417 ECHOCATH, INC. ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER 05/04/1995
K933450 ELECTRO-CATHETER CORP. CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION 04/19/1995
K844805 ELECTRO-CATHETER CORP. ELECATH GALLAGHER MAPPING CATHETER 01/02/1985
K933451 ELECTRO-CATHETER CORP. OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION 04/19/1995
K770341 ELECTRO-CATHETER CORP. TEMP. PROBE, & ELECTRONIC THERMOMETER 02/28/1977
K943257 ELECTRO-CATHETER CORP. TIP DEFLECTOR (GENESIS) 04/19/1995
K926549 ENDO-THERAPEUTICS, INC. ENDOCATH ELECTROPHYSIOLOGY CATHETER 12/06/1993
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
K940167 EP TECHNOLOGIES, INC. DIAGNOSTIC I CATHETER 08/02/1994
K940168 EP TECHNOLOGIES, INC. DIAGNOSTIC II CATHETER 07/27/1994
K881853 EP TECHNOLOGIES, INC. FRANZ CATHETER 07/18/1988
K892207 EP TECHNOLOGIES, INC. FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED 06/12/1989
K903880 EP TECHNOLOGIES, INC. FRANZ(TM) STEERABLE COMBINATION CATHETER 10/12/1990
K003452 EP TECHNOLOGIES, INC. POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D 12/07/2000
K900452 EP TECHNOLOGIES, INC. QUATTRO CATHETER 03/14/1990
K043257 EP TECHNOLOGIES, INC. REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM 02/03/2005
K924109 EP TECHNOLOGIES, INC. STEEROCATH II 12/16/1993
K913375 EP TECHNOLOGIES, INC. TORQUE TUBE STEEROCATH(TM) 10/25/1991
K924108 EP TECHNOLOGIES, INC. TRACFINDER II 12/16/1993
K962307 FIDUS MEDICAL TECHNOLOGY CORP. RHYDER DIAGNOSTIC CATHETER 09/17/1996
K963074 HARMAC MEDICAL PRODUCTS, INC. HARMAC QUADPOLAR MAPPING PACING CATHETER 06/25/1997
K932388 HEART RHYTHM TECHNOLOGIES, INC. HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER 05/31/1995
K990958 IRVINE BIOMEDICAL, INC. "ORTHOGONAL EP CATHETERS" 06/03/1999
K010471 IRVINE BIOMEDICAL, INC. AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 06/06/2001
K946333 IRVINE BIOMEDICAL, INC. IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER 07/18/1995
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
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
K102588 MEDTRONIC ABLATION FRONTIERS, LLC ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE 03/18/2011
K951347 MEDTRONIC CARDIORHYTHM MARINR SERIES EP DIAGNOSTI CATHETERS 05/10/1995
K931794 MEDTRONIC CARDIORHYTHM MARINR SERIES EP DIAGNOSTIC CATHETERS 06/06/1994
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
K033050 MEDTRONIC VASCULAR EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 03/26/2004
K914460 MEDTRONIC VASCULAR MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES 11/22/1991
K823434 MILLAR INSTRUMENTS, INC. MIKRO-TIP CATHETER PRESSURE TRANSDUCER 11/30/1982
K812944 MILLAR INSTRUMENTS, INC. MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. 11/16/1981
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
K895916 PRUCKA ENGINEERING, INC. PE INTERCARDIAC MAPPING SYSTEM (ICMS) 12/13/1989
K904747 PRUCKA ENGINEERING, INC. PEI PLAQUE ELECTRODE ARRAY 10/09/1991
K143481 RHYTHMIA MEDICAL, INC IntellaMap Orion High Resolution Mapping Catheter 1/8/2015
K122461 RHYTHMIA MEDICAL, INC RHYTHMIA MAPPING CATHETER 04/18/2013
K831528 SCIMED LIFE SYSTEMS, INC. MODEL TP THERMISTOR PROBE 06/30/1983
K770477 SHERWOOD MEDICAL INDUSTRIES CITADEL REFERENCE ELECTRODE 03/30/1977
K011766 ST. JUDE MEDICAL 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 07/03/2001
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 4/1/2015
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 7/15/2015
K013484 STEREOTAXIS, INC. TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH 05/02/2002
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
K834602 WEBSTER LABORATORIES, INC. SWITCHING UNIT ELECTRODE CATHETER 05/09/1984
K823361 WEBSTER LABORATORIES, INC. SWITCHING UNIT ELECTRODE CATHETERS 01/14/1983
K991060 ZCV ,INC. ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 04/06/2000
K915159 ZMI CORP. PEDIATRIC MULTI-FUNCTION ELECTRODES 02/07/1992
K011847 ZYNERGY CARDIO VASULAR (ZCV), INC. ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE 07/13/2001


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