Catheter, Electrode Recording, Or Probe, Electrode Recording
FDA product code DRF · Class II (moderate risk) · 21 CFR 870.1220 · Cardiovascular
185510(k) clearances
1PMA approvals
21recalls
Manufacturers
- Biosense Webster, Inc. 19
- Boston Scientific Corporation 14
- St Jude Medical 14
- Ep Technologies, Inc. 12
- Irvine Biomedical, Inc. 11
- C.R. Bard, Inc. 11
- Cordis Webster, Inc. 8
- Innovative Health, LLC 6
- Medtronic Cardiorhythm 5
- Cardima, Inc. 5
- Electro-Catheter Corp. 5
- Medtronic, Inc. 5
- Daig Corp. 3
- Mogul Enterprises 3
- Arrow Intl., Inc. 3
- Synaptic Medical Corporation 3
- Cardiac Pathways Corp. 3
- Ep Medsystems 3
- Medtronic Vascular 2
- Cardiac Assist Devices, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252794 | Vision-MR Diagnostic CatheterDRF · Traditional | Imricor Medical Systems, Inc. | 01/08/2026SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | Stereotaxis, Inc. | 07/23/2025SE |
| K250310 | VIKING Fixed Curve Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 06/27/2025SE |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional…DRF · Traditional | Boston Scientific Corporation | 11/01/2024SE |
| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | Synaptic Medical Corporation | 09/06/2024SE |
| K233397 | Cosine-10TM Diagnostic CatheterDRF · Traditional | Medtronic, Inc. | 12/02/2023SE |
| K233207 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 10/27/2023SE |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 09/29/2023SE |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional | Boston Scientific | 04/25/2023SE |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 12/30/2022SE |
| K220796 | IntellaMap Orion High Resolution Mapping CatheterDRF · Special | Boston Scientific Corporation | 06/10/2022SE |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology CatheterDRF · Traditional | Synaptic Medical Corporation | 02/14/2022SE |
| K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology…DRF · Traditional | CathRx, Ltd. | 02/10/2022SE |
| K211219 | LASSOSTAR NAV Circular Mapping CatheterDRF · Traditional | Biosense Webster, Inc. | 01/26/2022SE |
| K212593 | ViaCath, AcQRate Dx Steerable CatheterDRF · Traditional | Biotronick, Inc. | 10/15/2021SE |
| K211494 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 09/14/2021SE |
| K211375 | Blazer Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 09/10/2021SE |
| K201445 | MultiCath, AcQRate Dx Fixed Curve CatheterDRF · Traditional | Biotronik, Inc. | 09/02/2021SE |
| K203261 | Reprocessed Inquiry Steerable Diagnostic EP CatheterDRF · Special | Innovative Health, LLC | 03/05/2021SE |
| K193632 | LassoStar Circular Mapping CatheterDRF · Traditional | Biosense Webster, Inc. | 06/30/2020SE |
| K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology CatheterDRF · Traditional | Innovative Health, LLC | 12/11/2019SE |
| K192360 | IntellaMap Orion High Resolution Mapping CatheterDRF · Traditional | Boston Scientific Corporation | 10/25/2019SE |
| K192037 | Advisor VL Circular Mapping Catheter, Sensor EnabledDRF · Traditional | Abbott Medical | 09/17/2019SE |
| K190132 | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode CatheterDRF · Traditional | Medtronic | 07/30/2019SE |
| K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac…DRF · Traditional | Medtronic | 07/30/2019SE |
| K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterDRF · Traditional | Innovative Health, LLC | 07/01/2019SE |
| K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology CableDRF · Traditional | Baylis Medical Company, Inc. | 06/07/2019SE |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology CableDRF · Traditional | Baylis Medical Company, Inc. | 06/07/2019SE |
| K182386 | Reprocessed Supreme Diagnostic Electrophysiology CatheterDRF · Traditional | Innovative Health, LLC | 04/23/2019SE |
| K171277 | Reprocessed Inquiry Steerable Diagnostic EP CatheterDRF · Traditional | Innovative Health, LLC | 10/23/2017SE |
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…DRF · Traditional | St Jude Medical | 12/13/2016SE |
| K161769 | Reprocessed Supreme Diagnostic Electrophysiology CathetersDRF · Traditional | Innovative Health, LLC | 12/06/2016SE |
| K162892 | Achieve Advance Mapping CatheterDRF · Special | Medtronic, Inc. | 11/15/2016SE |
| K151139 | EasyMap MAP CatheterDRF · Traditional | Medfact Engineering GmbH | 10/18/2016SE |
| K153139 | Achieve ST Mapping Catheter, Catheter Connecting CableDRF · Traditional | Medtronic, Inc. | 05/06/2016SE |
| K160390 | Map-it Diagnostic Mapping CathetersDRF · Traditional | Access Point Technologies Ep, Inc. | 04/11/2016SE |
| K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…DRF · Special | St Jude Medical | 07/15/2015SE |
| K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter…DRF · Special | St Jude Medical | 04/01/2015SE |
| K143481 | IntellaMap Orion High Resolution Mapping CatheterDRF · Special | Rhythmia Medical, Inc. | 01/08/2015SE |
| K133028 | Rithm Id Electrophysiology CatheterDRF · Traditional | Synaptic Medical Limited | 03/04/2014SE |
| K130602 | Lasso Nav Duo Loop CatheterDRF · Traditional | Biosense Webster, Inc. | 08/14/2013SE |
| K122461 | Rhythmia Mapping CatheterDRF · Traditional | Rhythmia Medical, Inc. | 04/18/2013SE |
| K120544 | Response Electrophysiology Catheters with LumenDRF · Special | St Jude Medical | 03/19/2012SE |
| K113213 | Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2DRF · Special | Biosense Webster, Inc. | 12/05/2011SE |
| K101991 | Webster Duo-Decapolar CatheterDRF · Traditional | Biosense Webster, Inc. | 05/02/2011SE |
| K102588 | Achieve Mapping Catheter and Electrical CableDRF · Traditional | Medtronic Ablation Frontiers, LLC | 03/18/2011SE |
| K102721 | Livewire Electophysiology CatheterDRF · Special | St Jude Medical | 10/18/2010SE |
| K101955 | ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model…DRF · Traditional | St Jude Medical | 10/15/2010SE |
| K101623 | Inquiry Afocusii Diagnostic CatheterDRF · Traditional | St Jude Medical | 08/13/2010SE |
| K101345 | Webster CS Catheter with Ez Steer Technology, Webster CS Catheter with Ez Steer…DRF · Traditional | Biosense Webster, Inc. | 06/22/2010SE |
| K093376 | Lasso Nav CatheterDRF · Traditional | Biosense Webster, Inc. | 06/18/2010SE |
| K090898 | Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with…DRF · Special | Biosense Webster, Inc. | 09/04/2009SE |
| K091370 | Radia Steerable Diagnostic CatheterDRF · Special | C.R. Bard, Inc. | 06/05/2009SE |
| K081803 | St. Jude Medical Epicardial Catheter SystemDRF · Traditional | St Jude Medical | 05/13/2009SE |
| K090120 | Refstar Plus with Qwikpatch External Reference Patch, Model D-1210-03, Refstar Plus…DRF · Special | Biosense Webster, Inc. | 03/24/2009SE |
| K081576 | Blazer DX-20 Diagnostic CatheterDRF · Traditional | Boston Scientific Corp | 02/03/2009SE |
| K080179 | Reflexion HD High-Density Mapping CatheterDRF · Traditional | St Jude Medical | 01/07/2009SE |
| K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02DRF · Traditional | Biosense Webster, Inc. | 01/06/2009SE |
| K082061 | Inquiry H-Curve TV Steerable Diagnostic CatheterDRF · Special | Irvine Biomedical, Inc. | 08/19/2008SE |
| K080425 | CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02DRF · Traditional | Biosense Webster, Inc. | 04/23/2008SE |
| K072012 | Reflexion Spiral Variable Radius CatheterDRF · Special | St Jude Medical | 08/22/2007SE |
| K061678 | Prorhythm Promap Coaxial Mapping Catheter, Models PRI-MAP-15, PRI-MAP-20, PRI-MAP-25DRF · Traditional | Prorhythm | 01/12/2007SE |
| K062251 | Reflexion Spiral Variable Radius Catheter, Model 402804DRF · Traditional | St Jude Medical | 10/20/2006SE |
| K061468 | Refstar External Reference PatchDRF · Special | Biosense Webster, Inc. | 08/14/2006SE |
| K061463 | Esophageal Mapping Catheter, Model D-1272-01-SDRF · Traditional | Biosense Webster, Inc. | 08/14/2006SE |
| K060047 | Carto RMT Ep Navigation System V8DRF · Traditional | Biosense Webster, Inc. | 06/19/2006SE |
| K060757 | Inquiry Optima Plus Steerable Electrophysiology CatheterDRF · Special | Irvine Biomedical, Inc. | 04/19/2006SE |
| K053582 | Inquiry Afocus II Diagnostic CatheterDRF · Special | Irvine Biomedical, Inc. | 03/21/2006SE |
| K052083 | Navistar RMT Steerable Tip Diagnostic CatheterDRF · Traditional | Biosense Webster, Inc. | 09/29/2005SE |
| K042998 | Refstar RMT External Reference PatchDRF · Special | Biosense Webster, Inc. | 09/29/2005SE |
| K050877 | Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRDRF · Special | Biosense Webster, Inc. | 06/24/2005SE |
| K043257 | Real-Time Position Management (RPM) SystemDRF · Special | Ep Technologies, Inc. | 02/03/2005SE |
| K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterDRF · Special | Irvine Biomedical, Inc. | 11/04/2004SE |
| K042105 | Clipper Diagnostic Electrode CatheterDRF · Special | Bard Electrophysiology | 09/23/2004SE |
| K033963 | Ep Deflectable CathetersDRF · Special | Ep Medsystems, Inc. | 04/15/2004SE |
| K033050 | En Circlr Al Adjustable Loop Mapping Catheter Models, 1045AL1, 1045AL2, 1060AL1, 1060AL2DRF · Traditional | Medtronic Vascular | 03/26/2004SE |
| K030627 | Orbiter PV Diagnostic Electrode Catheter, Models 320100 & 320110DRF · Traditional | C.R. Bard, Inc. | 10/23/2003SE |
| K031161 | Variable Lasso 2515 Circular Mapping CatheterDRF · Special | Biosense Webster, Inc. | 07/22/2003SE |
| K030852 | 4 French & 5 French Electrophysiology Diagnostic Catheters Models 5UEXXX, 5BEXXX and…DRF · Special | Mogul Enterprises | 07/10/2003SE |
| K021421 | Padtac Electrophysiology Recording Catheters, Junction Cable Connector & CableDRF · Traditional | Tz Medical, Inc. | 04/18/2003SE |
| K022380 | Livesire Electrophysiology CatheterDRF · Traditional | St Jude Medical | 10/01/2002SE |
| K013484 | Telstar Magnetic Navigation Systems [Mns}, Telstar Bi-Plane Digital Imaging System…DRF · Traditional | Stereotaxis, Inc. | 05/02/2002SE |
| K012520 | Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20EDRF · Traditional | Cardiac Assist Devices, Inc. | 03/27/2002SE |
| K011361 | Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector CableDRF · Traditional | Catheffects, LLC | 09/06/2001SE |
| K011847 | Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory CableDRF · Special | Zynergy Cardio Vasular (Zcv), Inc. | 07/13/2001SE |
| K011766 | 6F Evaluator Electrophysiology Catheter, CRD # 402720,402722; 6F Eavuator…DRF · Special | St Jude Medical | 07/03/2001SE |
| K011734 | 6-FRENCH, 20-ELECTRODE Electrophysiology Diagnostic Catheter, Models 6U20XXX, 6B20XXX…DRF · Special | Mogul Enterprises | 07/03/2001SE |
| K010471 | Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569DRF · Special | Irvine Biomedical, Inc. | 06/06/2001SE |
| K002976 | Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX…DRF · Traditional | St Jude Medical | 12/22/2000SE |
| K003452 | Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DDRF · Special | Ep Technologies, Inc. | 12/07/2000SE |
| K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220DRF · Special | Biosense Webster, Inc. | 08/31/2000SE |
| K993698 | Slimcath-Dx Models, 3SUXXXX, 3SBXXXX, and FcxxxxDRF · Abbreviated | Mogul Enterprises | 08/16/2000SE |
| K991060 | Zynergy Zolution Electrophysiology Catheter, Model Z50000DRF · Traditional | Zcv ,Inc. | 04/06/2000SE |
| K000753 | Cordis 13F Catheter Sheath IntroducerDRF · Special | Cordis Corp. | 04/06/2000SE |
| K992912 | Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac…DRF · Traditional | Cardiac Pathways Corp. | 03/08/2000SE |
| K991878 | Luma-Cath Steerable Ep CathetersDRF · Traditional | Irvine Biomedical, Inc. | 12/10/1999SE |
| K992965 | Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085DRF · Traditional | Cordis Webster, Inc. | 11/26/1999SE |
| K992373 | Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension CableDRF · Traditional | C.R. Bard, Inc. | 11/05/1999SE |
| K991025 | Luma-Cath Fixed Curve Ep CathetersDRF · Special | Irvine Biomedical, Inc. | 10/15/1999SE |
| K991531 | Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078DRF · Traditional | Cordis Webster, Inc. | 10/04/1999SE |
| K991001 | Modification of Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology…DRF · Special | Ep Medsystems | 07/15/1999SE |
| K990958 | Orthogonal Ep CathetersDRF · Special | Irvine Biomedical, Inc. | 06/03/1999SE |
| K972803 | Tracer O-T-W Mapping DeviceDRF · Traditional | Cardima, Inc. | 05/11/1999SE |
| K984150 | Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology CatheterDRF · Special | Ep Medsystems | 02/22/1999SE |
| K983653 | Radii Diagnostic Electrophysiology Catheter, Model # 30411 B, C and DDRF · Traditional | Cardiac Pathways Corp. | 12/22/1998SE |
| K982835 | Electrode Switchbox, Model 11-081002DRF · Abbreviated | Cardima, Inc. | 10/29/1998SE |
| K982415 | Cordis Webster Ref-Star External Reference Patch, Model # D-1210DRF · Special | Cordis Webster, Inc. | 08/10/1998SE |
| K981642 | Stablemapr Steerable Intracardiac CathetersDRF · Traditional | Medtronic Cardiorhythm | 08/05/1998SE |
| K982232 | Modification of the IBI-1100 Steerable Electrophysiology Catheter SystemDRF · Special | Irvine Biomedical, Inc. | 07/25/1998SE |
| K971975 | Cardima Pathfinder 1.5F Mapping MicrocatheterDRF · Traditional | Cardima, Inc. | 07/01/1998SE |
| K980961 | Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02,-03, and -04.DRF · Traditional | Cordis Webster, Inc. | 05/28/1998SE |
| K973639 | Electrode Semi-Flotation Catheter by J-Lloyd Medical, Inc.DRF · Traditional | J-Lloyd Medical, Inc. | 04/20/1998SE |
| K971504 | Hexapolar Electrode Balloon Flotation CatheterDRF · Traditional | J-Lloyd Medical, Inc. | 04/20/1998SE |
| K970853 | Pathfinder 3MM Mapping Microcatheter (01-082001)DRF · Traditional | Cardima, Inc. | 11/04/1997SE |
| K971265 | Viking Diagnostic Electrode CatheterDRF · Traditional | C.R. Bard, Inc. | 10/23/1997SE |
| K965066 | Arrhythmia Mapping System (8100/8300)DRF · Traditional | Cardiac Pathways Corp. | 08/11/1997SE |
| K963074 | Harmac Quadpolar Mapping Pacing CatheterDRF · Traditional | Harmac Medical Products, Inc. | 06/25/1997SE |
| K961924 | IBI-1100 Steerable Electrophysiology Catheter SystemDRF · Traditional | Irvine Biomedical, Inc. | 04/11/1997SE |
| K955847 | Gyro Tip Ep CatheterDRF · Traditional | Cardiac Assist Devices, Inc. | 01/29/1997SE |
| K955802 | PathfinderDRF · Traditional | Cardima, Inc. | 01/29/1997SE |
| K964272 | Performr Series Ep Diagnostic CathetersDRF · Traditional | Medtronic Cardiorhythm | 01/23/1997SE |
| K954651 | Electrode Recording CatheterDRF · Traditional | Boston Scientific Corp | 10/22/1996SE |
| K953663 | Cordis Webster T20 Diagnostic Deflectable Tip CatheterDRF · Traditional | Cordis Webster, Inc. | 09/18/1996SE |
| K962307 | Rhyder Diagnostic CatheterDRF · Traditional | Fidus Medical Technology Corp. | 09/17/1996SE |
| K960542 | NogaDRF · Traditional | Biosense, Ltd. | 04/15/1996SE |
| K953185 | Platinum Series Ep Diagnostic CathetersDRF · Traditional | Medtronic Cardiorhythm | 04/15/1996SE |
| K955817 | Coridis Webster Deflectable Braided-Tip Electrode CatheterDRF · Traditional | Cordis Webster, Inc. | 03/25/1996SE |
| K953750 | Catheter, Electrode Recording, or Probe, Electrode RecordingDRF · Traditional | Boston Scientific Corp | 03/11/1996SE |
| K954390 | Cordis Wester Star CatheterDRF · Traditional | Cordis Webster, Inc. | 12/21/1995SE |
| K953651 | Diagnostic Electrophysiology Catheter SystemDRF · Traditional | Arrow Intl., Inc. | 11/30/1995SE |
| K953768 | Cordis Webster A20 Diagnostic Deflectable Tip CatheterDRF · Traditional | Cordis Webster, Inc. | 11/22/1995SE |
| K945229 | Arrow Multipolar Intracardiac Electrode CathetersDRF · Traditional | Arrow Intl., Inc. | 08/08/1995SE |
| K946333 | IBI-1000(TM) Electrophysiology CathterDRF · Traditional | Irvine Biomedical, Inc. | 07/18/1995SE |
| K932388 | HRT Series 100 Electrophysiology CatheterDRF · Traditional | Heart Rhythm Technologies, Inc. | 05/31/1995SE |
| K951347 | Marinr Series Ep Diagnosti CathetersDRF · Traditional | Medtronic Cardiorhythm | 05/10/1995SE |
| K951744 | Large Tip (4MM) Diagnostic-Electrohysiology CathetersDRF · Traditional | Boston Scientific Corp | 05/04/1995SE |
| K933417 | Echomark(R) Electrophysiology CatheterDRF · Traditional | Echocath, Inc. | 05/04/1995SE |
| K943257 | Tip Deflector (Genesis)DRF · Traditional | Electro-Catheter Corp. | 04/19/1995SE |
| K933451 | Open Tip Multi-Electrode Catheter, ModificationDRF · Traditional | Electro-Catheter Corp. | 04/19/1995SE |
| K933450 | Closed Tip Multi-Electrode Catheter, ModificationDRF · Traditional | Electro-Catheter Corp. | 04/19/1995SE |
| K942379 | Daig Diagnostic Electrophysiology CatheterDRF · Traditional | Daig Corp. | 12/27/1994SE |
| K940167 | Diagnostic I CatheterDRF · Traditional | Ep Technologies, Inc. | 08/02/1994SE |
| K940168 | Diagnostic II CatheterDRF · Traditional | Ep Technologies, Inc. | 07/27/1994SE |
| K931794 | Marinr Series Ep Diagnostic CathetersDRF · Traditional | Medtronic Cardiorhythm | 06/06/1994SE |
| K924109 | Steerocath IIDRF · Traditional | Ep Technologies, Inc. | 12/16/1993SE |
| K924108 | Tracfinder IIDRF · Traditional | Ep Technologies, Inc. | 12/16/1993SE |
| K926549 | Endocath Electrophysiology CatheterDRF · Traditional | Endo-Therapeutics, Inc. | 12/06/1993SE |
| K924163 | EXPLORER/360-POLARIS-L.E./JACKMAN Coron Sinus ElecDRF · Traditional | Boston Scientific Corp | 09/03/1993SE |
| K923916 | Voyagr Series Diagnostic Ep CathetersDRF · Traditional | Cardiorhythm | 02/10/1993SE |
| K923915 | Torqr Series Diagnostic Ep CathetersDRF · Traditional | Cardiorhythm | 02/10/1993SE |
| K911065 | Arrow Quadpolar Mapping/Pacing CatheterDRF · Traditional | Arrow Intl., Inc. | 06/18/1992SE |
| K915640 | Voyagr Series of Deflectable Diagostic Ep CatheterDRF · Traditional | Arrhythmia Technologies, Inc. | 03/09/1992SE |
| K915563 | Diagnostic Ep CatheterDRF · Traditional | Arrhythmia Technologies, Inc. | 03/09/1992SE |
| K914278 | Daig Electrophysiology Catheter W/Infusion LumenDRF · Traditional | Daig Corp. | 03/04/1992SE |
| K915159 | Pediatric Multi-Function ElectrodesDRF · Traditional | Zmi Corp. | 02/07/1992SE |
| K914460 | Medtronic Model 5407S, 5807S & 5410S Surg CablesDRF · Traditional | Medtronic Vascular | 11/22/1991SE |
| K913375 | Torque Tube Steerocath(Tm)DRF · Traditional | Ep Technologies, Inc. | 10/25/1991SE |
| K904747 | Pei Plaque Electrode ArrayDRF · Traditional | Prucka Engineering, Inc. | 10/09/1991SE |
| K911140 | Bard(R) Endocardial Balloon ArrayDRF · Traditional | C.R. Bard, Inc. | 05/07/1991SE |
| K905831 | Arzco Octapolar Esophageal Cardiac Record CathDRF · Traditional | Arzco Medical Electronics, Inc. | 03/29/1991SE |
| K903136 | Arzo Tapcath Esophageal Recording CatheterDRF · Traditional | Arzco Medical Electronics, Inc. | 01/18/1991SE |
| K903880 | Franz(Tm) Steerable Combination CatheterDRF · Traditional | Ep Technologies, Inc. | 10/12/1990SE |
| K902228 | Modified Epicardial ArrayDRF · Traditional | C.R. Bard, Inc. | 07/06/1990SE |
| K900765 | Steerocath(Tm)DRF · Traditional | Ep Technologies, Inc. | 05/07/1990SE |
| K900452 | Quattro CatheterDRF · Traditional | Ep Technologies, Inc. | 03/14/1990SE |
| K895916 | Pe Intercardiac Mapping System (Icms)DRF · Traditional | Prucka Engineering, Inc. | 12/13/1989SE |
| K894500 | Daig Electrophysiology CatheterDRF · Traditional | Daig Corp. | 09/18/1989SE |
| K893611 | Bard Plaque Electrode ArrayDRF · Traditional | Bard Electrophysiology | 07/14/1989SE |
| K892207 | Franz(Tm) Moveable Stylet Map Catheter, ModifiedDRF · Traditional | Ep Technologies, Inc. | 06/12/1989SE |
| K891908 | Bard(R) Tip Deflecting Electrode CatheterDRF · Traditional | C.R. Bard, Inc. | 06/05/1989SE |
| K881966 | Electrophysiology Electrode Cath. W/Silver/SilverDRF · Traditional | C.R. Bard, Inc. | 10/04/1988SE |
| K881853 | Franz CatheterDRF · Traditional | Ep Technologies, Inc. | 07/18/1988SE |
| K873995 | Bard Desai Catheter ElectrodeDRF · Traditional | C.R. Bard, Inc. | 01/07/1988SE |
| K874208 | Bard Octapolar Electrode CatheterDRF · Traditional | C.R. Bard, Inc. | 12/29/1987SE |
| K872231 | Bard Epicardial Electrode ArrayDRF · Traditional | C.R. Bard, Inc. | 10/09/1987SE |
| K844805 | Elecath Gallagher Mapping CatheterDRF · Traditional | Electro-Catheter Corp. | 01/02/1985SE |
| K834602 | Switching Unit Electrode CatheterDRF · Traditional | Webster Laboratories, Inc. | 05/09/1984SE |
| K831528 | Model TP Thermistor ProbeDRF · Traditional | Scimed Life Systems, Inc. | 06/30/1983SE |
| K823361 | Switching Unit Electrode CathetersDRF · Traditional | Webster Laboratories, Inc. | 01/14/1983SE |
| K823434 | Mikro-Tip Catheter Pressure TransducerDRF · Traditional | Millar Instruments, Inc. | 11/30/1982SE |
| K812944 | Millar Mikro-Tip Catheter Pressure Tran.DRF · Traditional | Millar Instruments, Inc. | 11/16/1981SE |
| K802058 | Mapping Probe Model #6540DRF · Traditional | Cardiac Pacemakers, Inc. | 11/19/1980SE |
| K770709 | Probe, Temperature, System, SarnsDRF · Traditional | 3M Health Care, Sarns | 04/27/1977SE |
| K770477 | Citadel Reference ElectrodeDRF · Traditional | Sherwood Medical Industries | 03/30/1977SE |
| K770341 | Temp. Probe, & Electronic ThermometerDRF · Traditional | Electro-Catheter Corp. | 02/28/1977SE |
PMA approvals
- P990025 Navi-Star Diagnostic/Ablation Deflectable Tip Catheter · Biosense Webster, Inc. · 06/15/2000
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3012-2020 Class II | Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR…Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model… | Irvine Biomedical Inc, a St. Jude Medical Co. | 08/24/2020Terminated |
| Z-3011-2020 Class II | Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR…Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model… | Irvine Biomedical Inc, a St. Jude Medical Co. | 08/24/2020Terminated |
| Z-3197-2018 Class II | ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code:…Products are labeled with an incorrect expiration date | Arrow International Inc | 07/30/2018Terminated |
| Z-0200-2016 Class II | Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable…64 units of Achieve Electrical Cables were shipped with a potential sterility breach. | Medtronic Inc. | 09/29/2015Terminated |
| Z-1525-2015 Class II | WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac…The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation… | Biosense Webster, Inc. | 04/17/2015Terminated |
| Z-1242-2015 Class II | LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03…Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty… | Biosense Webster, Inc. | 02/25/2015Terminated |
| Z-0580-2015 Class II | IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog…Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond… | Boston Scientific Corp | 11/20/2014Terminated |
| Z-0177-2015 Class II | St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response… | St Jude Medical | 10/14/2014Terminated |
| Z-1617-2013 Class II | 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate…Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated… | Biosense Webster, Inc. | 06/19/2013Terminated |
| Z-2667-2011 | LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers…The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes… | Biosense Webster, Inc. | 05/23/2011Terminated |
| Z-2666-2011 | LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers…The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes… | Biosense Webster, Inc. | 05/23/2011Terminated |
| Z-2665-2011 | HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number…The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes… | Biosense Webster, Inc. | 05/23/2011Terminated |
| Z-2664-2011 | ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog #…The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes… | Biosense Webster, Inc. | 05/23/2011Terminated |
| Z-3038-2011 | Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog…The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers… | Biosense Webster, Inc. | 04/29/2011Terminated |
| Z-3037-2011 | ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number…The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers… | Biosense Webster, Inc. | 04/29/2011Terminated |
| Z-1704-2008 | Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping…This recall was initiated after the firm received several complaints reporting issues with deflection. The… | Biosense Webster Inc | 03/25/2008Terminated |
| Z-1703-2008 | Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping…This recall was initiated after the firm received several complaints reporting issues with deflection. The… | Biosense Webster Inc | 03/25/2008Terminated |
| Z-1618-2008 | Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific…Package sterile barrier may be breached, compromising sterility. | Boston Scientific Corp | 02/14/2008Terminated |
| Z-1617-2008 | Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general…Package sterile barrier may be breached, compromising sterility. | Boston Scientific Corp | 02/14/2008Terminated |
| Z-1647-2012 | EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter…The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010… | Biosense Webster, Inc. | 12/15/2007Terminated |
| Z-1191-2007 | Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes). | Boston Scientific Corp | 06/26/2007Terminated |