FDA Product Code
FDA Product Code DRF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1220
510(k) Clearances — 185 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252794 | Vision-MR Diagnostic Catheter | Imricor Medical Systems, Inc. | 2026-01-08 | Traditional | PDF ↗ |
| K250590 | MAGiC Sweep EP Mapping Catheter | Stereotaxis, Inc. | 2025-07-23 | Traditional | PDF ↗ |
| K250310 | VIKING Fixed Curve Diagnostic Catheter | Boston Scientific Corporation | 2025-06-27 | Traditional | PDF ↗ |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2024-11-01 | Traditional | PDF ↗ |
| K233900 | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | 2024-09-06 | Traditional | PDF ↗ |
| K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | 2023-12-02 | Traditional | PDF ↗ |
| K233207 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023-10-27 | Special | PDF ↗ |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023-09-29 | Special | PDF ↗ |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable | Boston Scientific | 2023-04-25 | Traditional | PDF ↗ |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | Shanghai Microport EP Medtech Co., Ltd. | 2022-12-30 | Traditional | PDF ↗ |
| K220796 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2022-06-10 | Special | PDF ↗ |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Synaptic Medical Corporation | 2022-02-14 | Traditional | PDF ↗ |
| K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters | CathRx, Ltd. | 2022-02-10 | Traditional | PDF ↗ |
| K211219 | LASSOSTAR NAV Circular Mapping Catheter | Biosense Webster, Inc. | 2022-01-26 | Traditional | PDF ↗ |
| K212593 | ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. | 2021-10-15 | Traditional | PDF ↗ |
| K211494 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021-09-14 | Traditional | PDF ↗ |
| K211375 | Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021-09-10 | Traditional | PDF ↗ |
| K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | Biotronik, Inc. | 2021-09-02 | Traditional | PDF ↗ |
| K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2021-03-05 | Special | PDF ↗ |
| K193632 | LassoStar Circular Mapping Catheter | Biosense Webster, Inc. | 2020-06-30 | Traditional | PDF ↗ |
| K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019-12-11 | Traditional | PDF ↗ |
| K192360 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2019-10-25 | Traditional | PDF ↗ |
| K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | ABBOTT MEDICAL | 2019-09-17 | Traditional | PDF ↗ |
| K190132 | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Medtronic | 2019-07-30 | Traditional | PDF ↗ |
| K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Medtronic | 2019-07-30 | Traditional | PDF ↗ |
| K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC | 2019-07-01 | Traditional | PDF ↗ |
| K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | Baylis Medical Company, Inc. | 2019-06-07 | Traditional | PDF ↗ |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | Baylis Medical Company, Inc. | 2019-06-07 | Traditional | PDF ↗ |
| K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019-04-23 | Traditional | PDF ↗ |
| K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2017-10-23 | Traditional | PDF ↗ |
| 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 | St Jude Medical | 2016-12-13 | Traditional | PDF ↗ |
| K161769 | Reprocessed Supreme Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2016-12-06 | Traditional | PDF ↗ |
| K162892 | Achieve Advance Mapping Catheter | Medtronic, Inc. | 2016-11-15 | Special | PDF ↗ |
| K151139 | EasyMap MAP Catheter | Medfact Engineering GmbH | 2016-10-18 | Traditional | PDF ↗ |
| K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | Medtronic, Inc. | 2016-05-06 | Traditional | PDF ↗ |
| K160390 | Map-it Diagnostic Mapping Catheters | Access Point Technologies Ep, Inc. | 2016-04-11 | Traditional | PDF ↗ |
| 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 | St Jude Medical | 2015-07-15 | Special | PDF ↗ |
| K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter | St Jude Medical | 2015-04-01 | Special | PDF ↗ |
| K143481 | IntellaMap Orion High Resolution Mapping Catheter | Rhythmia Medical, Inc. | 2015-01-08 | Special | PDF ↗ |
| K133028 | RITHM ID ELECTROPHYSIOLOGY CATHETER | Synaptic Medical Limited | 2014-03-04 | Traditional | PDF ↗ |
| K130602 | LASSO NAV DUO LOOP CATHETER | Biosense Webster, Inc. | 2013-08-14 | Traditional | PDF ↗ |
| K122461 | RHYTHMIA MAPPING CATHETER | Rhythmia Medical, Inc. | 2013-04-18 | Traditional | PDF ↗ |
| K120544 | RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN | St Jude Medical | 2012-03-19 | Special | PDF ↗ |
| K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | Biosense Webster, Inc. | 2011-12-05 | Special | PDF ↗ |
| K101991 | WEBSTER DUO-DECAPOLAR CATHETER | Biosense Webster, Inc. | 2011-05-02 | Traditional | PDF ↗ |
| K102588 | ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE | Medtronic Ablation Frontiers, LLC | 2011-03-18 | Traditional | PDF ↗ |
| K102721 | LIVEWIRE ELECTOPHYSIOLOGY CATHETER | St Jude Medical | 2010-10-18 | Special | PDF ↗ |
| K101955 | ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 | St Jude Medical | 2010-10-15 | Traditional | PDF ↗ |
| K101623 | INQUIRY AFOCUSII DIAGNOSTIC CATHETER | St Jude Medical | 2010-08-13 | Traditional | PDF ↗ |
| K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, | Biosense Webster, Inc. | 2010-06-22 | Traditional | PDF ↗ |
| K093376 | LASSO NAV CATHETER | Biosense Webster, Inc. | 2010-06-18 | Traditional | PDF ↗ |
| K090898 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER | Biosense Webster, Inc. | 2009-09-04 | Special | PDF ↗ |
| K091370 | RADIA STEERABLE DIAGNOSTIC CATHETER | C.R. Bard, Inc. | 2009-06-05 | Special | PDF ↗ |
| K081803 | ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM | St Jude Medical | 2009-05-13 | Traditional | PDF ↗ |
| K090120 | REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 | Biosense Webster, Inc. | 2009-03-24 | Special | PDF ↗ |
| K081576 | BLAZER DX-20 DIAGNOSTIC CATHETER | Boston Scientific Corp | 2009-02-03 | Traditional | PDF ↗ |
| K080179 | REFLEXION HD HIGH-DENSITY MAPPING CATHETER | St Jude Medical | 2009-01-07 | Traditional | PDF ↗ |
| K081258 | VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 | Biosense Webster, Inc. | 2009-01-06 | Traditional | PDF ↗ |
| K082061 | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER | Irvine Biomedical, Inc. | 2008-08-19 | Special | PDF ↗ |
| K080425 | CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 | Biosense Webster, Inc. | 2008-04-23 | Traditional | PDF ↗ |
| K072012 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER | St Jude Medical | 2007-08-22 | Special | PDF ↗ |
| K061678 | PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 | Prorhythm | 2007-01-12 | Traditional | PDF ↗ |
| K062251 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 | St Jude Medical | 2006-10-20 | Traditional | PDF ↗ |
| K061468 | REFSTAR EXTERNAL REFERENCE PATCH | Biosense Webster, Inc. | 2006-08-14 | Special | PDF ↗ |
| K061463 | ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S | Biosense Webster, Inc. | 2006-08-14 | Traditional | PDF ↗ |
| K060047 | CARTO RMT EP NAVIGATION SYSTEM V8 | Biosense Webster, Inc. | 2006-06-19 | Traditional | PDF ↗ |
| K060757 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER | Irvine Biomedical, Inc. | 2006-04-19 | Special | PDF ↗ |
| K053582 | INQUIRY AFOCUS II DIAGNOSTIC CATHETER | Irvine Biomedical, Inc. | 2006-03-21 | Special | PDF ↗ |
| K042998 | REFSTAR RMT EXTERNAL REFERENCE PATCH | Biosense Webster, Inc. | 2005-09-29 | Special | PDF ↗ |
| K052083 | NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER | Biosense Webster, Inc. | 2005-09-29 | Traditional | PDF ↗ |
| K050877 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR | Biosense Webster, Inc. | 2005-06-24 | Special | PDF ↗ |
| K043257 | REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM | Ep Technologies, Inc. | 2005-02-03 | Special | PDF ↗ |
| K042775 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER | Irvine Biomedical, Inc. | 2004-11-04 | Special | PDF ↗ |
| K042105 | CLIPPER DIAGNOSTIC ELECTRODE CATHETER | Bard Electrophysiology | 2004-09-23 | Special | PDF ↗ |
| K033963 | EP DEFLECTABLE CATHETERS | Ep Medsystems, Inc. | 2004-04-15 | Special | PDF ↗ |
| K033050 | EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 | Medtronic Vascular | 2004-03-26 | Traditional | PDF ↗ |
| K030627 | ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 | C.R. Bard, Inc. | 2003-10-23 | Traditional | PDF ↗ |
| K031161 | VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER | Biosense Webster, Inc. | 2003-07-22 | Special | PDF ↗ |
| K030852 | 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX | Mogul Enterprises | 2003-07-10 | Special | PDF ↗ |
| K021421 | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE | Tz Medical, Inc. | 2003-04-18 | Traditional | PDF ↗ |
| K022380 | LIVESIRE ELECTROPHYSIOLOGY CATHETER | St Jude Medical | 2002-10-01 | Traditional | PDF ↗ |
| K013484 | TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH | Stereotaxis, Inc. | 2002-05-02 | Traditional | PDF ↗ |
| K012520 | GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E | Cardiac Assist Devices, Inc. | 2002-03-27 | Traditional | PDF ↗ |
| K011361 | DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE | Catheffects, LLC | 2001-09-06 | Traditional | PDF ↗ |
| K011847 | ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE | Zynergy Cardio Vasular (Zcv), Inc. | 2001-07-13 | Special | PDF ↗ |
| K011766 | 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 | St Jude Medical | 2001-07-03 | Special | PDF ↗ |
| K011734 | 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX | Mogul Enterprises | 2001-07-03 | Special | PDF ↗ |
| K010471 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 | Irvine Biomedical, Inc. | 2001-06-06 | Special | PDF ↗ |
| K002976 | RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX | St Jude Medical | 2000-12-22 | Traditional | PDF ↗ |
| K003452 | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D | Ep Technologies, Inc. | 2000-12-07 | Special | PDF ↗ |
| K002333 | BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 | Biosense Webster, Inc. | 2000-08-31 | Special | PDF ↗ |
| K993698 | SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX | Mogul Enterprises | 2000-08-16 | Abbreviated | PDF ↗ |
| K991060 | ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 | Zcv ,Inc. | 2000-04-06 | Traditional | PDF ↗ |
| K000753 | CORDIS 13F CATHETER SHEATH INTRODUCER | Cordis Corp. | 2000-04-06 | Special | PDF ↗ |
| K992912 | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH | Cardiac Pathways Corp. | 2000-03-08 | Traditional | PDF ↗ |
| K991878 | LUMA-CATH STEERABLE EP CATHETERS | Irvine Biomedical, Inc. | 1999-12-10 | Traditional | PDF ↗ |
| K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | Cordis Webster, Inc. | 1999-11-26 | Traditional | PDF ↗ |
| K992373 | ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE | C.R. Bard, Inc. | 1999-11-05 | Traditional | PDF ↗ |
| K991025 | LUMA-CATH FIXED CURVE EP CATHETERS | Irvine Biomedical, Inc. | 1999-10-15 | Special | PDF ↗ |
| K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | Cordis Webster, Inc. | 1999-10-04 | Traditional | PDF ↗ |
Product code DRF · Class II · Cardiovascular. Data: openFDA.