Product Code: DRF
FDA class 2
21 CFR 870.1220
Catheter, Electrode Recording, Or Probe, Electrode Recording
Cardiovascular
The Electrode Recording Catheter (or Electrode Recording Probe) is a cardiovascular electrophysiology device used intracardiac or intravascularly to record electrical signals from within the heart or blood vessels, aiding in the diagnosis of arrhythmias and other cardiac conditions. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRF and it is regulated under 21 CFR 870.1220 within the Cardiovascular medical specialty.
510(k)s
183
FEI Numbers
86
Registration Numbers
86
Unique Applicants
66
Years Active
48
Basic Information
- Product Code
- DRF
- Device Class
- FDA class 2
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 183 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250310 | VIKING Fixed Curve Diagnostic Catheter | Jun 27, 2025 | Substantially Equivalent | Boston Scientific Corporation |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter | Nov 01, 2024 | Substantially Equivalent | Boston Scientific Corporation |
| K233900 | Nordica PV Cryo Mapping Catheter | Sep 06, 2024 | Substantially Equivalent | Synaptic Medical Corporation |
| K233397 | Cosine-10TM Diagnostic Catheter | Dec 02, 2023 | Substantially Equivalent | Medtronic, Inc. |
| K233207 | Polaris X Unidirectional Steerable Diagnostic Catheter | Oct 27, 2023 | Substantially Equivalent | Boston Scientific Corporation |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter | Sep 29, 2023 | Substantially Equivalent | Boston Scientific Corporation |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable | Apr 25, 2023 | Substantially Equivalent | Boston Scientific |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | Dec 30, 2022 | Substantially Equivalent | Shanghai MicroPort EP MedTech Co., Ltd. |
| K220796 | IntellaMap Orion High Resolution Mapping Catheter | Jun 10, 2022 | Substantially Equivalent | Boston Scientific Corporation |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Feb 14, 2022 | Substantially Equivalent | Synaptic Medical Corporation |
| K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters | Feb 10, 2022 | Substantially Equivalent | CathRxLtd |
| K211219 | LASSOSTAR NAV Circular Mapping Catheter | Jan 26, 2022 | Substantially Equivalent | Biosense Webster, Inc. |
| K212593 | ViaCath, AcQRate Dx Steerable Catheter | Oct 15, 2021 | Substantially Equivalent | Biotronick, Inc. |
| K211494 | Polaris X Unidirectional Steerable Diagnostic Catheter | Sep 14, 2021 | Substantially Equivalent | Boston Scientific Corporation |
| K211375 | Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter | Sep 10, 2021 | Substantially Equivalent | Boston Scientific Corporation |
| K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | Sep 02, 2021 | Substantially Equivalent | Biotronik, Inc |
| K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Mar 05, 2021 | Substantially Equivalent | Innovative Health, LLC. |
| K193632 | LassoStar Circular Mapping Catheter | Jun 30, 2020 | Substantially Equivalent | Biosense Webster, Inc. |
| K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | Dec 11, 2019 | Substantially Equivalent | Innovative Health, LLC. |
| K192360 | IntellaMap Orion High Resolution Mapping Catheter | Oct 25, 2019 | Substantially Equivalent | Boston Scientific Corporation |
| K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | Sep 17, 2019 | Substantially Equivalent | Abbott Medical |
| K190132 | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Jul 30, 2019 | Substantially Equivalent | Medtronic |
| K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Jul 30, 2019 | Substantially Equivalent | Medtronic |
| K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Jul 01, 2019 | Substantially Equivalent | Innovative Health, LLC. |
| K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | Jun 07, 2019 | Substantially Equivalent | Baylis Medical Company Inc. |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | Jun 07, 2019 | Substantially Equivalent | Baylis Medical Company Inc. |
| K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter | Apr 23, 2019 | Substantially Equivalent | Innovative Health, LLC. |
| K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Oct 23, 2017 | Substantially Equivalent | Innovative Health, LLC. |
| K160335 | 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 | Dec 13, 2016 | Substantially Equivalent | St. Jude Medical |
| K161769 | Reprocessed Supreme Diagnostic Electrophysiology Catheters | Dec 06, 2016 | Substantially Equivalent | INNOVATIVE HEALTH, LLC. |
| K162892 | Achieve Advance Mapping Catheter | Nov 15, 2016 | Substantially Equivalent | MEDTRONIC INC. |
| K151139 | EasyMap MAP Catheter | Oct 18, 2016 | Substantially Equivalent | MedFact Engineering GmbH |
| K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | May 06, 2016 | Substantially Equivalent | MEDTRONIC, INC. |
| K160390 | Map-it Diagnostic Mapping Catheters | Apr 11, 2016 | Substantially Equivalent | ACCESS POINT TECHNOLOGIES EP, INC. |
| K151622 | 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 Electrophysiology Catheter | Jul 15, 2015 | Substantially Equivalent | St. Jude Medical |
| K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter | Apr 01, 2015 | Substantially Equivalent | St. Jude Medical |
| K143481 | IntellaMap Orion High Resolution Mapping Catheter | Jan 08, 2015 | Substantially Equivalent | RHYTHMIA MEDICAL, INC |
| K133028 | RITHM ID ELECTROPHYSIOLOGY CATHETER | Mar 04, 2014 | Substantially Equivalent | SYNAPTIC MEDICAL LIMITED |
| K130602 | LASSO NAV DUO LOOP CATHETER | Aug 14, 2013 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K122461 | RHYTHMIA MAPPING CATHETER | Apr 18, 2013 | Substantially Equivalent | RHYTHMIA MEDICAL, INC |
| K120544 | RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN | Mar 19, 2012 | Substantially Equivalent | ST. JUDE MEDICAL |
| K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | Dec 05, 2011 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K101991 | WEBSTER DUO-DECAPOLAR CATHETER | May 02, 2011 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K102588 | ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE | Mar 18, 2011 | Substantially Equivalent | MEDTRONIC ABLATION FRONTIERS, LLC |
| K102721 | LIVEWIRE ELECTOPHYSIOLOGY CATHETER | Oct 18, 2010 | Substantially Equivalent | ST. JUDE MEDICAL |
| K101955 | ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 | Oct 15, 2010 | Substantially Equivalent | ST. JUDE MEDICAL |
| K101623 | INQUIRY AFOCUSII DIAGNOSTIC CATHETER | Aug 13, 2010 | Substantially Equivalent | ST. JUDE MEDICAL |
| K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, | Jun 22, 2010 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K093376 | LASSO NAV CATHETER | Jun 18, 2010 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K090898 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER | Sep 04, 2009 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K091370 | RADIA STEERABLE DIAGNOSTIC CATHETER | Jun 05, 2009 | Substantially Equivalent | C.R. BARD, INC. |
| K081803 | ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM | May 13, 2009 | Substantially Equivalent | ST. JUDE MEDICAL |
| K090120 | REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 | Mar 24, 2009 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K081576 | BLAZER DX-20 DIAGNOSTIC CATHETER | Feb 03, 2009 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K080179 | REFLEXION HD HIGH-DENSITY MAPPING CATHETER | Jan 07, 2009 | Substantially Equivalent | ST. JUDE MEDICAL |
| K081258 | VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 | Jan 06, 2009 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K082061 | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER | Aug 19, 2008 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K080425 | CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 | Apr 23, 2008 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K072012 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER | Aug 22, 2007 | Substantially Equivalent | ST. JUDE MEDICAL |
| K061678 | PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 | Jan 12, 2007 | Substantially Equivalent | PRORHYTHM |
| K062251 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 | Oct 20, 2006 | Substantially Equivalent | ST. JUDE MEDICAL |
| K061468 | REFSTAR EXTERNAL REFERENCE PATCH | Aug 14, 2006 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K061463 | ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S | Aug 14, 2006 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K060047 | CARTO RMT EP NAVIGATION SYSTEM V8 | Jun 19, 2006 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K060757 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER | Apr 19, 2006 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K053582 | INQUIRY AFOCUS II DIAGNOSTIC CATHETER | Mar 21, 2006 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K052083 | NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER | Sep 29, 2005 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K042998 | REFSTAR RMT EXTERNAL REFERENCE PATCH | Sep 29, 2005 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K050877 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR | Jun 24, 2005 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K043257 | REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM | Feb 03, 2005 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K042775 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER | Nov 04, 2004 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K042105 | CLIPPER DIAGNOSTIC ELECTRODE CATHETER | Sep 23, 2004 | Substantially Equivalent | BARD ELECTROPHYSIOLOGY |
| K033963 | EP DEFLECTABLE CATHETERS | Apr 15, 2004 | Substantially Equivalent | EP MEDSYSTEMS, INC. |
| K033050 | EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 | Mar 26, 2004 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K030627 | ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 | Oct 23, 2003 | Substantially Equivalent | C.R. BARD, INC. |
| K031161 | VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER | Jul 22, 2003 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K030852 | 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX | Jul 10, 2003 | Substantially Equivalent | MOGUL ENTERPRISES |
| K021421 | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE | Apr 18, 2003 | Substantially Equivalent | TZ MEDICAL, INC. |
| K022380 | LIVESIRE ELECTROPHYSIOLOGY CATHETER | Oct 01, 2002 | Substantially Equivalent | ST. JUDE MEDICAL |
| K013484 | TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH | May 02, 2002 | Substantially Equivalent | STEREOTAXIS, INC. |
| K012520 | GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E | Mar 27, 2002 | Substantially Equivalent | CARDIAC ASSIST DEVICES, INC. |
| K011361 | DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE | Sep 06, 2001 | Substantially Equivalent | CATHEFFECTS, LLC. |
| K011847 | ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE | Jul 13, 2001 | Substantially Equivalent | ZYNERGY CARDIO VASULAR (ZCV), INC. |
| K011766 | 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 | Jul 03, 2001 | Substantially Equivalent | ST. JUDE MEDICAL |
| K011734 | 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX | Jul 03, 2001 | Substantially Equivalent | MOGUL ENTERPRISES |
| K010471 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 | Jun 06, 2001 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K002976 | RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX | Dec 22, 2000 | Substantially Equivalent | ST. JUDE MEDICAL |
| K003452 | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D | Dec 07, 2000 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K002333 | BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 | Aug 31, 2000 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K993698 | SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX | Aug 16, 2000 | Substantially Equivalent | MOGUL ENTERPRISES |
| K991060 | ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 | Apr 06, 2000 | Substantially Equivalent | ZCV ,INC. |
| K000753 | CORDIS 13F CATHETER SHEATH INTRODUCER | Apr 06, 2000 | Substantially Equivalent | CORDIS CORP. |
| K992912 | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH | Mar 08, 2000 | Substantially Equivalent | CARDIAC PATHWAYS CORP. |
| K991878 | LUMA-CATH STEERABLE EP CATHETERS | Dec 10, 1999 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | Nov 26, 1999 | Substantially Equivalent | CORDIS WEBSTER, INC. |
| K992373 | ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE | Nov 05, 1999 | Substantially Equivalent | C.R. BARD, INC. |
| K991025 | LUMA-CATH FIXED CURVE EP CATHETERS | Oct 15, 1999 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | Oct 04, 1999 | Substantially Equivalent | CORDIS WEBSTER, INC. |
| K991001 | MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | Jul 15, 1999 | Substantially Equivalent | EP MEDSYSTEMS |
| K990958 | ORTHOGONAL EP CATHETERS | Jun 03, 1999 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K972803 | TRACER O-T-W MAPPING DEVICE | May 11, 1999 | Substantially Equivalent | CARDIMA, INC. |
| K984150 | PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | Feb 22, 1999 | Substantially Equivalent | EP MEDSYSTEMS |
| K983653 | RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D | Dec 22, 1998 | Substantially Equivalent | CARDIAC PATHWAYS CORP. |
| K982835 | ELECTRODE SWITCHBOX, MODEL 11-081002 | Oct 29, 1998 | Substantially Equivalent | CARDIMA, INC. |
| K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | Aug 10, 1998 | Substantially Equivalent | CORDIS WEBSTER, INC. |
| K981642 | STABLEMAPR STEERABLE INTRACARDIAC CATHETERS | Aug 05, 1998 | Substantially Equivalent | MEDTRONIC CARDIORHYTHM |
| K982232 | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | Jul 25, 1998 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K971975 | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER | Jul 01, 1998 | Substantially Equivalent | CARDIMA, INC. |
| K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | May 28, 1998 | Substantially Equivalent | CORDIS WEBSTER, INC. |
| K973639 | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. | Apr 20, 1998 | Substantially Equivalent | J-LLOYD MEDICAL, INC. |
| K971504 | HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER | Apr 20, 1998 | Substantially Equivalent | J-LLOYD MEDICAL, INC. |
| K970853 | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) | Nov 04, 1997 | Substantially Equivalent | CARDIMA, INC. |
| K971265 | VIKING DIAGNOSTIC ELECTRODE CATHETER | Oct 23, 1997 | Substantially Equivalent | C.R. BARD, INC. |
| K965066 | ARRHYTHMIA MAPPING SYSTEM (8100/8300) | Aug 11, 1997 | Substantially Equivalent | CARDIAC PATHWAYS CORP. |
| K963074 | HARMAC QUADPOLAR MAPPING PACING CATHETER | Jun 25, 1997 | Substantially Equivalent | HARMAC MEDICAL PRODUCTS, INC. |
| K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | Apr 11, 1997 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K955847 | GYRO TIP EP CATHETER | Jan 29, 1997 | Substantially Equivalent | CARDIAC ASSIST DEVICES, INC. |
| K955802 | PATHFINDER | Jan 29, 1997 | Substantially Equivalent | CARDIMA, INC. |
| K964272 | PERFORMR SERIES EP DIAGNOSTIC CATHETERS | Jan 23, 1997 | Substantially Equivalent | MEDTRONIC CARDIORHYTHM |
| K954651 | ELECTRODE RECORDING CATHETER | Oct 22, 1996 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | Sep 18, 1996 | Substantially Equivalent | CORDIS WEBSTER, INC. |
| K962307 | RHYDER DIAGNOSTIC CATHETER | Sep 17, 1996 | Substantially Equivalent | FIDUS MEDICAL TECHNOLOGY CORP. |
| K960542 | NOGA | Apr 15, 1996 | Substantially Equivalent | BIOSENSE, LTD. |
| K953185 | PLATINUM SERIES EP DIAGNOSTIC CATHETERS | Apr 15, 1996 | Substantially Equivalent | MEDTRONIC CARDIORHYTHM |
| K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | Mar 25, 1996 | Substantially Equivalent | CORDIS WEBSTER, INC. |
| K953750 | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | Mar 11, 1996 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K954390 | CORDIS WESTER STAR CATHETER | Dec 21, 1995 | Substantially Equivalent | CORDIS WEBSTER, INC. |
| K953651 | DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM | Nov 30, 1995 | Substantially Equivalent | ARROW INTL., INC. |
| K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | Nov 22, 1995 | Substantially Equivalent | CORDIS WEBSTER, INC. |
| K945229 | ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS | Aug 08, 1995 | Substantially Equivalent | ARROW INTL., INC. |
| K946333 | IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER | Jul 18, 1995 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. |
| K932388 | HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER | May 31, 1995 | Substantially Equivalent | HEART RHYTHM TECHNOLOGIES, INC. |
| K951347 | MARINR SERIES EP DIAGNOSTI CATHETERS | May 10, 1995 | Substantially Equivalent | MEDTRONIC CARDIORHYTHM |
| K951744 | LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS | May 04, 1995 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K933417 | ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER | May 04, 1995 | Substantially Equivalent | ECHOCATH, INC. |
| K943257 | TIP DEFLECTOR (GENESIS) | Apr 19, 1995 | Substantially Equivalent | ELECTRO-CATHETER CORP. |
| K933451 | OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION | Apr 19, 1995 | Substantially Equivalent | ELECTRO-CATHETER CORP. |
| K933450 | CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION | Apr 19, 1995 | Substantially Equivalent | ELECTRO-CATHETER CORP. |
| K942379 | DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | Dec 27, 1994 | Substantially Equivalent | DAIG CORP. |
| K940167 | DIAGNOSTIC I CATHETER | Aug 02, 1994 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K940168 | DIAGNOSTIC II CATHETER | Jul 27, 1994 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K931794 | MARINR SERIES EP DIAGNOSTIC CATHETERS | Jun 06, 1994 | Substantially Equivalent | MEDTRONIC CARDIORHYTHM |
| K924109 | STEEROCATH II | Dec 16, 1993 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K924108 | TRACFINDER II | Dec 16, 1993 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K926549 | ENDOCATH ELECTROPHYSIOLOGY CATHETER | Dec 06, 1993 | Substantially Equivalent | ENDO-THERAPEUTICS, INC. |
| K924163 | EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC | Sep 03, 1993 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K923916 | VOYAGR SERIES DIAGNOSTIC EP CATHETERS | Feb 10, 1993 | Substantially Equivalent | CARDIORHYTHM |
| K923915 | TORQR SERIES DIAGNOSTIC EP CATHETERS | Feb 10, 1993 | Substantially Equivalent | CARDIORHYTHM |
| K911065 | ARROW QUADPOLAR MAPPING/PACING CATHETER | Jun 18, 1992 | Substantially Equivalent | ARROW INTL., INC. |
| K915640 | VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER | Mar 09, 1992 | Substantially Equivalent | ARRHYTHMIA TECHNOLOGIES, INC. |
| K915563 | DIAGNOSTIC EP CATHETER | Mar 09, 1992 | Substantially Equivalent | ARRHYTHMIA TECHNOLOGIES, INC. |
| K914278 | DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN | Mar 04, 1992 | Substantially Equivalent | DAIG CORP. |
| K915159 | PEDIATRIC MULTI-FUNCTION ELECTRODES | Feb 07, 1992 | Substantially Equivalent | ZMI CORP. |
| K914460 | MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES | Nov 22, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K913375 | TORQUE TUBE STEEROCATH(TM) | Oct 25, 1991 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K904747 | PEI PLAQUE ELECTRODE ARRAY | Oct 09, 1991 | Substantially Equivalent | PRUCKA ENGINEERING, INC. |
| K911140 | BARD(R) ENDOCARDIAL BALLOON ARRAY | May 07, 1991 | Substantially Equivalent | C.R. BARD, INC. |
| K905831 | ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH | Mar 29, 1991 | Substantially Equivalent | ARZCO MEDICAL ELECTRONICS, INC. |
| K903136 | ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER | Jan 18, 1991 | Substantially Equivalent | ARZCO MEDICAL ELECTRONICS, INC. |
| K903880 | FRANZ(TM) STEERABLE COMBINATION CATHETER | Oct 12, 1990 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K902228 | MODIFIED EPICARDIAL ARRAY | Jul 06, 1990 | Substantially Equivalent | C.R. BARD, INC. |
| K900765 | STEEROCATH(TM) | May 07, 1990 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K900452 | QUATTRO CATHETER | Mar 14, 1990 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K895916 | PE INTERCARDIAC MAPPING SYSTEM (ICMS) | Dec 13, 1989 | Substantially Equivalent | PRUCKA ENGINEERING, INC. |
| K894500 | DAIG ELECTROPHYSIOLOGY CATHETER | Sep 18, 1989 | Substantially Equivalent | DAIG CORP. |
| K893611 | BARD PLAQUE ELECTRODE ARRAY | Jul 14, 1989 | Substantially Equivalent | BARD ELECTROPHYSIOLOGY |
| K892207 | FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED | Jun 12, 1989 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K891908 | BARD(R) TIP DEFLECTING ELECTRODE CATHETER | Jun 05, 1989 | Substantially Equivalent | C.R. BARD, INC. |
| K881966 | ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER | Oct 04, 1988 | Substantially Equivalent | C.R. BARD, INC. |
| K881853 | FRANZ CATHETER | Jul 18, 1988 | Substantially Equivalent | EP TECHNOLOGIES, INC. |
| K873995 | BARD DESAI CATHETER ELECTRODE | Jan 07, 1988 | Substantially Equivalent | C.R. BARD, INC. |
| K874208 | BARD OCTAPOLAR ELECTRODE CATHETER | Dec 29, 1987 | Substantially Equivalent | C.R. BARD, INC. |
| K872231 | BARD EPICARDIAL ELECTRODE ARRAY | Oct 09, 1987 | Substantially Equivalent | C.R. BARD, INC. |
| K844805 | ELECATH GALLAGHER MAPPING CATHETER | Jan 02, 1985 | Substantially Equivalent | ELECTRO-CATHETER CORP. |
| K834602 | SWITCHING UNIT ELECTRODE CATHETER | May 09, 1984 | Substantially Equivalent | WEBSTER LABORATORIES, INC. |
| K831528 | MODEL TP THERMISTOR PROBE | Jun 30, 1983 | Substantially Equivalent | SCIMED LIFE SYSTEMS, INC. |
| K823361 | SWITCHING UNIT ELECTRODE CATHETERS | Jan 14, 1983 | Substantially Equivalent | WEBSTER LABORATORIES, INC. |
| K823434 | MIKRO-TIP CATHETER PRESSURE TRANSDUCER | Nov 30, 1982 | Substantially Equivalent | MILLAR INSTRUMENTS, INC. |
| K812944 | MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. | Nov 16, 1981 | Substantially Equivalent | MILLAR INSTRUMENTS, INC. |
| K802058 | MAPPING PROBE MODEL #6540 | Nov 19, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K770709 | PROBE, TEMPERATURE, SYSTEM, SARNS | Apr 27, 1977 | Substantially Equivalent | 3M HEALTH CARE, SARNS |
| K770477 | CITADEL REFERENCE ELECTRODE | Mar 30, 1977 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
| K770341 | TEMP. PROBE, & ELECTRONIC THERMOMETER | Feb 28, 1977 | Substantially Equivalent | ELECTRO-CATHETER CORP. |
FEI Numbers
This FDA classification entry is associated with 86 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 86 registration numbers. Click on an entry to view related FDA registrations.