Atlas FDA

DRF

185 FDA 510(k) clearances · Product code

114 daysmedian time to decision
378 days90th percentile
185clearances measured

FDA profile

Official device name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1220
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 625 · 2022: 613 · 2023: 685 · 2024: 623 · 2025: 514 · 2026: 218
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Vision-MR™ Diagnostic Catheter (K252794)Imricor Medical Systems, Inc.2026-01-08
MAGiC Sweep™ EP Mapping Catheter (K250590)Stereotaxis, Inc.2025-07-23
VIKING™ Fixed Curve Diagnostic Catheter (K250310)Boston Scientific Corporation2025-06-27
EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter (K240366)Boston Scientific Corporation2024-11-01
Nordica PV Cryo Mapping Catheter (K233900)Synaptic Medical Corporation2024-09-06
Cosine-10TM Diagnostic Catheter (K233397)Medtronic, Inc.2023-12-02
Polaris X™ Unidirectional Steerable Diagnostic Catheter (K233207)Boston Scientific Corporation2023-10-27
BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K232651)Boston Scientific Corporation2023-09-29
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (K230503)Boston Scientific2023-04-25
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (K210313)Shanghai Microport EP Medtech Co., Ltd.2022-12-30
IntellaMap Orion High Resolution Mapping Catheter (K220796)Boston Scientific Corporation2022-06-10
RithmID-SD Steerable Diagnostic Electrophysiology Catheter (K203793)Synaptic Medical Corporation2022-02-14
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters (K211327)CathRx, Ltd.2022-02-10
LASSOSTAR NAV Circular Mapping Catheter (K211219)Biosense Webster, Inc.2022-01-26
ViaCath, AcQRate Dx Steerable Catheter (K212593)Biotronick, Inc.2021-10-15
Polaris X Unidirectional Steerable Diagnostic Catheter (K211494)Boston Scientific Corporation2021-09-14
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K211375)Boston Scientific Corporation2021-09-10
MultiCath, AcQRate Dx Fixed Curve Catheter (K201445)Biotronik, Inc.2021-09-02
Reprocessed Inquiry Steerable Diagnostic EP Catheter (K203261)Innovative Health, LLC2021-03-05
LassoStar Circular Mapping Catheter (K193632)Biosense Webster, Inc.2020-06-30
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter (K191880)Innovative Health, LLC2019-12-11
IntellaMap Orion High Resolution Mapping Catheter (K192360)Boston Scientific Corporation2019-10-25
Advisor VL Circular Mapping Catheter, Sensor Enabled (K192037)ABBOTT MEDICAL2019-09-17
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter (K183547)Medtronic2019-07-30
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter (K190132)Medtronic2019-07-30
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (K190980)Innovative Health, LLC2019-07-01
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable (K183649)Baylis Medical Company, Inc.2019-06-07
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable (K183632)Baylis Medical Company, Inc.2019-06-07
Reprocessed Supreme Diagnostic Electrophysiology Catheter (K182386)Innovative Health, LLC2019-04-23
Reprocessed Inquiry Steerable Diagnostic EP Catheter (K171277)Innovative Health, LLC2017-10-23
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 (K160335)St Jude Medical2016-12-13
Reprocessed Supreme Diagnostic Electrophysiology Catheters (K161769)Innovative Health, LLC2016-12-06
Achieve Advance Mapping Catheter (K162892)Medtronic, Inc.2016-11-15
EasyMap MAP Catheter (K151139)Medfact Engineering GmbH2016-10-18
Achieve ST Mapping Catheter, Catheter Connecting Cable (K153139)Medtronic, Inc.2016-05-06
Map-it Diagnostic Mapping Catheters (K160390)Access Point Technologies Ep, Inc.2016-04-11
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 (K151622)St Jude Medical2015-07-15
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter (K150631)St Jude Medical2015-04-01
IntellaMap Orion High Resolution Mapping Catheter (K143481)Rhythmia Medical, Inc.2015-01-08
RITHM ID ELECTROPHYSIOLOGY CATHETER (K133028)Synaptic Medical Limited2014-03-04
LASSO NAV DUO LOOP CATHETER (K130602)Biosense Webster, Inc.2013-08-14
RHYTHMIA MAPPING CATHETER (K122461)Rhythmia Medical, Inc.2013-04-18
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN (K120544)St Jude Medical2012-03-19
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 (K113213)Biosense Webster, Inc.2011-12-05
WEBSTER DUO-DECAPOLAR CATHETER (K101991)Biosense Webster, Inc.2011-05-02
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE (K102588)Medtronic Ablation Frontiers, LLC2011-03-18
LIVEWIRE ELECTOPHYSIOLOGY CATHETER (K102721)St Jude Medical2010-10-18
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 (K101955)St Jude Medical2010-10-15
INQUIRY AFOCUSII DIAGNOSTIC CATHETER (K101623)St Jude Medical2010-08-13
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, (K101345)Biosense Webster, Inc.2010-06-22
LASSO NAV CATHETER (K093376)Biosense Webster, Inc.2010-06-18
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER (K090898)Biosense Webster, Inc.2009-09-04
RADIA STEERABLE DIAGNOSTIC CATHETER (K091370)C.R. Bard, Inc.2009-06-05
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM (K081803)St Jude Medical2009-05-13
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 (K090120)Biosense Webster, Inc.2009-03-24
BLAZER DX-20 DIAGNOSTIC CATHETER (K081576)Boston Scientific Corp2009-02-03
REFLEXION HD HIGH-DENSITY MAPPING CATHETER (K080179)St Jude Medical2009-01-07
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 (K081258)Biosense Webster, Inc.2009-01-06
INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER (K082061)Irvine Biomedical, Inc.2008-08-19
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 (K080425)Biosense Webster, Inc.2008-04-23
REFLEXION SPIRAL VARIABLE RADIUS CATHETER (K072012)St Jude Medical2007-08-22
PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 (K061678)Prorhythm2007-01-12
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 (K062251)St Jude Medical2006-10-20
REFSTAR EXTERNAL REFERENCE PATCH (K061468)Biosense Webster, Inc.2006-08-14
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S (K061463)Biosense Webster, Inc.2006-08-14
CARTO RMT EP NAVIGATION SYSTEM V8 (K060047)Biosense Webster, Inc.2006-06-19
INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER (K060757)Irvine Biomedical, Inc.2006-04-19
INQUIRY AFOCUS II DIAGNOSTIC CATHETER (K053582)Irvine Biomedical, Inc.2006-03-21
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER (K052083)Biosense Webster, Inc.2005-09-29
REFSTAR RMT EXTERNAL REFERENCE PATCH (K042998)Biosense Webster, Inc.2005-09-29
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR (K050877)Biosense Webster, Inc.2005-06-24
REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM (K043257)Ep Technologies, Inc.2005-02-03
INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER (K042775)Irvine Biomedical, Inc.2004-11-04
CLIPPER DIAGNOSTIC ELECTRODE CATHETER (K042105)Bard Electrophysiology2004-09-23
EP DEFLECTABLE CATHETERS (K033963)Ep Medsystems, Inc.2004-04-15
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 (K033050)Medtronic Vascular2004-03-26
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 (K030627)C.R. Bard, Inc.2003-10-23
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER (K031161)Biosense Webster, Inc.2003-07-22
4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX (K030852)Mogul Enterprises2003-07-10
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE (K021421)Tz Medical, Inc.2003-04-18
LIVESIRE ELECTROPHYSIOLOGY CATHETER (K022380)St Jude Medical2002-10-01
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH (K013484)Stereotaxis, Inc.2002-05-02
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E (K012520)Cardiac Assist Devices, Inc.2002-03-27
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE (K011361)Catheffects, LLC2001-09-06
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE (K011847)Zynergy Cardio Vasular (Zcv), Inc.2001-07-13
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX (K011734)Mogul Enterprises2001-07-03
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 (K011766)St Jude Medical2001-07-03
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 (K010471)Irvine Biomedical, Inc.2001-06-06
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX (K002976)St Jude Medical2000-12-22
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D (K003452)Ep Technologies, Inc.2000-12-07
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 (K002333)Biosense Webster, Inc.2000-08-31
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX (K993698)Mogul Enterprises2000-08-16
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 (K991060)Zcv ,Inc.2000-04-06
CORDIS 13F CATHETER SHEATH INTRODUCER (K000753)Cordis Corp.2000-04-06
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH (K992912)Cardiac Pathways Corp.2000-03-08
LUMA-CATH STEERABLE EP CATHETERS (K991878)Irvine Biomedical, Inc.1999-12-10
CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 (K992965)Cordis Webster, Inc.1999-11-26
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE (K992373)C.R. Bard, Inc.1999-11-05
LUMA-CATH FIXED CURVE EP CATHETERS (K991025)Irvine Biomedical, Inc.1999-10-15
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 (K991531)Cordis Webster, Inc.1999-10-04
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