DRF · Class II · 21 CFR 870.1220

FDA Product Code DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

Electrophysiology studies require precise mapping of electrical activity within the heart. FDA product code DRF covers electrode recording catheters and electrode probes used in cardiac electrophysiology.

These catheters are equipped with multiple electrode contacts that simultaneously record intracardiac electrograms from different locations, enabling the identification and mapping of arrhythmia substrates before ablation therapy.

DRF devices are Class II medical devices, regulated under 21 CFR 870.1220 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Biosense Webster, Inc., St Jude Medical and Ep Technologies, Inc..

186
Total
186
Cleared
169d
Avg days
1977
Since
186 devices
73–96 of 186
Cleared Feb 03, 2005
REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM
K043257
Ep Technologies, Inc.
Cardiovascular · 71d
Cleared Nov 04, 2004
INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
K042775
Irvine Biomedical, Inc.
Cardiovascular · 29d
Cleared Sep 23, 2004
CLIPPER DIAGNOSTIC ELECTRODE CATHETER
K042105
Bard Electrophysiology
Cardiovascular · 50d
Cleared Apr 15, 2004
EP DEFLECTABLE CATHETERS
K033963
Ep Medsystems, Inc.
Cardiovascular · 115d
Cleared Mar 26, 2004
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
K033050
Medtronic Vascular
Cardiovascular · 179d
Cleared Oct 23, 2003
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
K030627
C.R. Bard, Inc.
Cardiovascular · 238d
Cleared Jul 22, 2003
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
K031161
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared Jul 10, 2003
4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX
K030852
Mogul Enterprises
Cardiovascular · 114d
Cleared Apr 18, 2003
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
K021421
Tz Medical, Inc.
Cardiovascular · 350d
Cleared Oct 01, 2002
LIVESIRE ELECTROPHYSIOLOGY CATHETER
K022380
St Jude Medical
Cardiovascular · 71d
Cleared May 02, 2002
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH
K013484
Stereotaxis, Inc.
Cardiovascular · 195d
Cleared Mar 27, 2002
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
K012520
Cardiac Assist Devices, Inc.
Cardiovascular · 233d
Cleared Sep 06, 2001
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
K011361
Catheffects, LLC
Cardiovascular · 126d
Cleared Jul 13, 2001
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
K011847
Zynergy Cardio Vasular (Zcv), Inc.
Cardiovascular · 30d
Cleared Jul 03, 2001
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
K011734
Mogul Enterprises
Cardiovascular · 28d
Cleared Jul 03, 2001
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766
St Jude Medical
Cardiovascular · 26d
Cleared Jun 06, 2001
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
K010471
Irvine Biomedical, Inc.
Cardiovascular · 106d
Cleared Dec 22, 2000
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
K002976
St Jude Medical
Cardiovascular · 88d
Cleared Dec 07, 2000
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
K003452
Ep Technologies, Inc.
Cardiovascular · 30d
Cleared Aug 31, 2000
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Aug 16, 2000
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
K993698
Mogul Enterprises
Cardiovascular · 288d
Cleared Apr 06, 2000
CORDIS 13F CATHETER SHEATH INTRODUCER
K000753
Cordis Corp.
Cardiovascular · 29d
Cleared Apr 06, 2000
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
K991060
Zcv ,Inc.
Cardiovascular · 373d
Cleared Mar 08, 2000
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
K992912
Cardiac Pathways Corp.
Cardiovascular · 191d