ClearanceBrief
Panels › Cardiovascular › Product code DRF · Class 2

Catheter, Electrode Recording, Or Probe, Electrode Recording

Regulation 870.1220

2510(k)s in 12 months (186 all time)
0recalls in 12 months (26 all time)
19recalls that name a 510(k)
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Top companies in DRF

Company510(k)sRecalls
Biosense Webster, Inc.1915
Boston Scientific145
St Jude Medical141
Ep Technologies, Inc.120
C.R. Bard, Inc.110
Irvine Biomedical, Inc.110
Cordis Webster, Inc.80
Innovative Health, LLC60
Medtronic51
Cardima, Inc.50
Decided510(k)Device and applicantCode
Jun 22, 2010K101345WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
Biosense Webster, Inc.
DRF
Jun 18, 2010K093376LASSO NAV CATHETER
Biosense Webster, Inc.
DRF
Sep 4, 2009K090898CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER
Biosense Webster, Inc.
DRF
Jun 5, 2009K091370RADIA STEERABLE DIAGNOSTIC CATHETER
C.R. Bard, Inc.
DRF
May 13, 2009K081803ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
St Jude Medical
DRF
Mar 24, 2009K090120REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
Biosense Webster, Inc.
DRF
Feb 3, 2009K081576BLAZER DX-20 DIAGNOSTIC CATHETER
Boston Scientific Corp
DRF
Jan 7, 2009K080179REFLEXION HD HIGH-DENSITY MAPPING CATHETER
St Jude Medical
DRF
Jan 6, 2009K081258VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
Biosense Webster, Inc.
DRF
Aug 19, 2008K082061INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
Irvine Biomedical, Inc.
DRF
Apr 23, 2008K080425CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
Biosense Webster, Inc.
DRF
Aug 22, 2007K072012REFLEXION SPIRAL VARIABLE RADIUS CATHETER
St Jude Medical
DRF
Jan 12, 2007K061678PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25
Prorhythm
DRF
Oct 20, 2006K062251REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
St Jude Medical
DRF
Aug 14, 2006K061468REFSTAR EXTERNAL REFERENCE PATCH
Biosense Webster, Inc.
DRF
Aug 14, 2006K061463ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
Biosense Webster, Inc.
DRF
Jun 19, 2006K060047CARTO RMT EP NAVIGATION SYSTEM V8
Biosense Webster, Inc.
DRF
Apr 19, 2006K060757INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
Irvine Biomedical, Inc.
DRF
Mar 21, 2006K053582INQUIRY AFOCUS II DIAGNOSTIC CATHETER
Irvine Biomedical, Inc.
DRF
Sep 29, 2005K052083NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
Biosense Webster, Inc.
DRF
Sep 29, 2005K042998REFSTAR RMT EXTERNAL REFERENCE PATCH
Biosense Webster, Inc.
DRF
Jun 24, 2005K050877CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
Biosense Webster, Inc.
DRF
Feb 3, 2005K043257REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM
Ep Technologies, Inc.
DRF
Nov 4, 2004K042775INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
Irvine Biomedical, Inc.
DRF
Sep 23, 2004K042105CLIPPER DIAGNOSTIC ELECTRODE CATHETER
Bard Electrophysiology
DRF
Apr 15, 2004K033963EP DEFLECTABLE CATHETERS
Ep Medsystems, Inc.
DRF
Mar 26, 2004K033050EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
Medtronic Vascular
DRF
Oct 23, 2003K030627ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
C.R. Bard, Inc.
DRF
Jul 22, 2003K031161VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
Biosense Webster, Inc.
DRF
Jul 10, 2003K0308524 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX
Mogul Enterprises
DRF
Apr 18, 2003K021421PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
Tz Medical, Inc.
DRF
Oct 1, 2002K022380LIVESIRE ELECTROPHYSIOLOGY CATHETER
St Jude Medical
DRF
May 2, 2002K013484TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH
Stereotaxis, Inc.
DRF
Mar 27, 2002K012520GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
Cardiac Assist Devices, Inc.
DRF
Sep 6, 2001K011361DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
Catheffects, LLC
DRF
Jul 13, 2001K011847ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
Zynergy Cardio Vasular (Zcv), Inc.
DRF
Jul 3, 2001K0117666F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027
St Jude Medical
DRF
Jul 3, 2001K0117346-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
Mogul Enterprises
DRF
Jun 6, 2001K010471AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
Irvine Biomedical, Inc.
DRF
Dec 22, 2000K002976RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
St Jude Medical
DRF
Dec 7, 2000K003452POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
Ep Technologies, Inc.
DRF
Aug 31, 2000K002333BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
Biosense Webster, Inc.
DRF
Aug 16, 2000K993698SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
Mogul Enterprises
DRF
Apr 6, 2000K991060ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
Zcv ,Inc.
DRF
Apr 6, 2000K000753CORDIS 13F CATHETER SHEATH INTRODUCER
Cordis Corp.
DRF
Mar 8, 2000K992912CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
Cardiac Pathways Corp.
DRF
Dec 10, 1999K991878LUMA-CATH STEERABLE EP CATHETERS
Irvine Biomedical, Inc.
DRF
Nov 26, 1999K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
Cordis Webster, Inc.
DRF
Nov 5, 1999K992373ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
C.R. Bard, Inc.
DRF
Oct 15, 1999K991025LUMA-CATH FIXED CURVE EP CATHETERS
Irvine Biomedical, Inc.
DRF

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