Cable, Transducer And Electrode, Patient, (Including Connector)
FDA product code DSA · Class II (moderate risk) · 21 CFR 870.2900 · Cardiovascular
105510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Medtronic Vascular 5
- Tronomed, Inc. 4
- Arbo Medical, Inc. 3
- Vyaire Medical 3
- Beijing Rongrui-Century Science & Technology Co., Ltd. 2
- Ewc 2
- Curbell Electronics, Inc. 2
- Conmedcorp 2
- Sentry Medical Products, Inc. 2
- Remington Medical, Inc. 2
- Pace Medical 2
- Unimed Medical Supplies, Inc. 2
- The LE Blanc Corp. 2
- Shenzhen Med-Link Electronics Tech Co., Ltd. 2
- Shenzhen Changke Connect Electronics Co., Ltd. 2
- Shenzhen Coreray Technology, Ltd. 2
- Custom Cardio Components 2
- R2 Corp. 2
- Boston Scientific Corporation 2
- C.R. Bard, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254114 | Baylis Connector CableDSA · Special | Baylis Medical Technologies, Inc. | 01/18/2026SE |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott…DSA · Traditional | Drägerwerk AG & Co. KGaA | 12/01/2025SE |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger…DSA · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 09/30/2025SE |
| K242986 | SpO2 Extension CableDSA · Special | Beijing Rongrui-Century Science & Technology… | 05/02/2025SE |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional | Philips Medizin Systeme Böblingen GmbH | 01/17/2025SE |
| K240087 | RT Carbon ECG LeadsDSA · Traditional | Ivy Biomedical Systems, Inc. | 09/13/2024SE |
| K240377 | LIFEPAK® ECG CablesDSA · Traditional | Stryker Physio-Control | 05/07/2024SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | Physio-Control, Inc. | 04/30/2024SE |
| K222712 | Fogg System Patient Monitoring CablesDSA · Traditional | Fogg System Company, Inc. | 11/22/2023SE |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | Baylis Medical Technologies, Inc. | 05/30/2023SE |
| K222370 | SpO2 Extension CableDSA · Traditional | Beijing Rongrui-Century Science & Technology… | 04/02/2023SE |
| K220447 | Med-link Disposable ECG Cable and LeadwiresDSA · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 06/28/2022SE |
| K211941 | 9LineDSA · Traditional | Energetic Designs, Inc. | 01/27/2022SE |
| K211294 | Multi-Link X2 ECG Cable and Leadwire SystemDSA · Traditional | Vyaire Medical, Inc. | 08/16/2021SE |
| K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient CablesDSA · Traditional | Medtronic, Inc. | 07/12/2021SE |
| K200722 | PCA-C1 series Patient CableDSA · Traditional | QT Medical, Inc. | 06/03/2021SE |
| K203635 | Patient Monitoring CablesDSA · Traditional | Jkh USA, LLC | 02/05/2021SE |
| K200510 | Multi-LinkTM X2 ECG Adapter and LeadwiresDSA · Traditional | Vyaire Medical, Inc. | 10/09/2020SE |
| K201359 | ECG Cables and LeadwiresDSA · Traditional | Xinkang Medical Instrument Co. , Ltd. | 10/01/2020SE |
| K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor…DSA · Abbreviated | Atrility Medical, LLC | 07/02/2020SE |
| K192404 | Patient Monitoring Cable (SpO2 Extension Cable)DSA · Traditional | Shenzhen Coreray Technology, Ltd. | 06/22/2020SE |
| K200026 | Disposable ECG CableDSA · Traditional | Shenzhen Changke Connect Electronics Co., Ltd. | 05/12/2020SE |
| K181089 | SureLead Cable SystemDSA · Traditional | Authentic Medical | 01/17/2020SE |
| K191428 | ECG CableDSA · Traditional | Shenzhen Changke Connect Electronics Co., Ltd. | 11/27/2019SE |
| K191273 | Multi-Link X2 ECG and SpO2 AdapterDSA · Traditional | Vyaire Medical, Inc. | 09/13/2019SE |
| K190078 | IntraSightDSA · Special | Volcano Corporation | 02/11/2019SE |
| K182327 | Patient Cables and Leadwires , Disposable ECG LeadwiresDSA · Traditional | Orantech, Inc. | 01/30/2019SE |
| K182220 | Curbell branded Patient Monitoring CablesDSA · Special | Curbell Medical Products, Inc. | 11/07/2018SE |
| K181726 | Medline Patient Cables and Lead WiresDSA · Traditional | Medline Industries, Inc. | 09/20/2018SE |
| K172797 | ECG Cable/LeadwiresDSA · Traditional | Shenzhen Coreray Technology, Ltd. | 02/28/2018SE |
| K172591 | Fixed Patient Leads ECG Cable (Model 3153)DSA · Special | Boston Scientific Corporation | 11/03/2017SE |
| K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP…DSA · Abbreviated | Integral Process Sas | 08/16/2017SE |
| K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemDSA · Traditional | Carefusion 303, Inc. | 06/22/2017SE |
| K170536 | ECG Disposable Lead WireDSA · Traditional | APK Technology Co., Ltd. | 04/24/2017SE |
| K162432 | Multi-Link X2 ECG Cable and Lead Wire SystemDSA · Traditional | Carefusion 2200, Inc. | 01/18/2017SE |
| K153188 | Caremed patient cable and leadwiresDSA · Traditional | Shenzhen Caremed Medical Technology Co., Ltd. | 10/24/2016SE |
| K152947 | Disposable Temporary Pacing CableDSA · Traditional | Tiger Medical Products | 04/05/2016SE |
| K142489 | Unimed Disposable ECG lead wiresDSA · Traditional | Unimed Medical Supplies, Inc. | 11/04/2014SE |
| K132253 | Removable Patient Leads ECG CableDSA · Traditional | Boston Scientific | 12/16/2013SE |
| K120010 | Cable/ Lead-Wire (ECG, EKG, SPO2 and Invasive Blood Pressure)DSA · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 01/19/2012SE |
| K110287 | Philips ECG Leadwire SetDSA · Abbreviated | Philips Medical Systems | 02/15/2011SE |
| K102430 | Tyco Electronics Electrocardiograph (ECG) Leadwire SetDSA · Traditional | Tyco Electronics Corporation | 09/10/2010SE |
| K101660 | ECG Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8DSA · Traditional | Kepler Medtec | 08/11/2010SE |
| K093858 | Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ADSA · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 04/02/2010SE |
| K093657 | Adagio Retracting ECG Lead WiresDSA · Traditional | Acist Medical Systems, Inc. | 01/15/2010SE |
| K082851 | Multlink Cable and Leadwire SystemDSA · Traditional | Ge Medical Systems Information Technologies | 11/19/2008SE |
| K082959 | Patient Monitoring Cables for ECG, EKG, SPO2 and Blood Pressure MonitorsDSA · Traditional | Unimed Medical Supplies, Inc. | 10/10/2008SE |
| K081762 | Curbell Patient Monitoring CablesDSA · Abbreviated | Curbell Electronics, Inc. | 08/27/2008SE |
| K080112 | Patient CableDSA · Traditional | Med-Dyne | 06/20/2008SE |
| K080605 | Sure-Lock Electrode Clip, Model CL-34, CL-A60, Cl-Hw, Cl-TlDSA · Special | Curbell Electronics, Inc. | 05/05/2008SE |
| K080621 | Fastlock, Model PC175M01, PC175MCE, PC005R01DSA · Traditional | European Custom Manufacturing BV | 04/29/2008SE |
| K071751 | Lifesync Adapter, Model LS-302DSA · Abbreviated | Lifesync Corporation | 08/27/2007SE |
| K070232 | ECG Cables, Trunk and Patient Lead WiresDSA · Abbreviated | American I.V. Products, Inc. | 03/27/2007SE |
| K062577 | V1 Multi-Port Connector, Model Pad V1-MPCDSA · Traditional | Tz Medical, Inc. | 12/15/2006SE |
| K043572 | Compatibility ECG Trunk CablesDSA · Traditional | Datex-Ohmeda | 02/22/2005SE |
| K030005 | Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory CablesDSA · Traditional | Vanguard Medical Concepts, Inc. | 03/18/2003SE |
| K023334 | BMC Catheter Connector Cable, Model RFP-101DSA · Traditional | Baylis Medical Co., Inc. | 12/31/2002SE |
| K022075 | Disposable Temporary Pacing Cable,Models CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC…DSA · Traditional | Cp Medical | 09/19/2002SE |
| K013598 | Reuse Claim for the Bard Electrophysiology Surelink, Templink, and Templink M Extension…DSA · Traditional | C.R. Bard, Inc. | 01/11/2002SE |
| K012392 | Disposable Surgical Extension Cable, Model 4255 and Model 4260DSA · Traditional | Pace Medical | 09/04/2001SE |
| K010809 | Bioconnect Patient Monitoring Cables and Leadwires, Cat# 1000 Thru Cat# 40000DSA · Traditional | Rf Industries, Ltd. | 05/23/2001SE |
| K002781 | Medical Cables Patient Monitoring Cables for ECG, EEG, SPO2, and Blood Pressure MonitorsDSA · Abbreviated | Medical Cables, Inc. | 11/29/2000SE |
| K001390 | Biosense Webster Patient Cable and LeadwiresDSA · Abbreviated | Biosense Webster, Inc. | 07/21/2000SE |
| K992524 | Patient Cables for Monitoring, I.E., ECG, EKG, SPO2, and BP Interface Cables and LeadwiresDSA · Traditional | Advantage Medical Electronics, Inc. | 03/01/2000SE |
| K984263 | Ewc: ECG II Cable Leadwire SystemDSA · Abbreviated | Ewc | 02/02/1999SE |
| K982817 | Ewc: ECG Cable and Leadwire SystemsDSA · Traditional | Ewc | 09/23/1998SE |
| K980806 | Affinity Medical Patient Cable SystemDSA · Traditional | Affinity Medical Technologies, LLC | 03/25/1998SE |
| K980582 | Multi-Link Cable and Lead Wire SystemsDSA · Traditional | Marquette Medical Systems, Inc. | 03/16/1998SE |
| K971968 | Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97)DSA · Traditional | Remington Medical, Inc. | 07/23/1997SE |
| K954900 | 3M Red Dot ECG Lead Wires aDSA · Traditional | Minnesota Mining and Mfg. Co. | 07/15/1996SE |
| K960446 | Model 5471 & 5471L Sterile Disposable Patient Cable AssembliesDSA · Traditional | Medtronic Vascular | 05/22/1996SE |
| K952659 | Tronomate Patient Cable & Leadwire SystemDSA · Traditional | Tronomed, Inc. | 01/11/1996SE |
| K940323 | Arbo Diagnostic ECG Patient Cables & Leadwires Arbo Shielded Multi-Lead Cable & Lead…DSA · Traditional | Arbo Medical, Inc. | 04/12/1995SE |
| K940302 | Arbo Monitring Safety Cable & Lead Wire Systems/Arbo Unsheilded Safety Cable & Lead SystemDSA · Traditional | Arbo Medical, Inc. | 11/30/1994SE |
| K940322 | Arbo VS Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead WireDSA · Traditional | Arbo Medical, Inc. | 11/28/1994SE |
| K942321 | Variouspatient Monitoring CableDSA · Traditional | Merit Cables Incorporated | 11/04/1994SE |
| K945034 | Conmed ECG Patient Safety Cables and Leadwires-Removal and Permanently-Attached LeadwiresDSA · Traditional | Conmedcorp | 10/27/1994SE |
| K941839 | Disposable Surgical CableDSA · Traditional | Conmed Andover Medical, Inc. | 07/27/1994SE |
| K941058 | Procath Pacing Threshold CableDSA · Traditional | Professional Catheter Corp. | 07/11/1994SE |
| K933649 | Conmed ECG Patient Cables and LeadwiresDSA · Traditional | Conmedcorp | 02/18/1994SE |
| K933603 | LeadwireDSA · Traditional | Sentry Medical Products, Inc. | 01/18/1994SE |
| K932704 | Patient CableDSA · Traditional | Sentry Medical Products, Inc. | 12/27/1993SE |
| K922009 | Disposable Surgical Extension Cable Model S-101DSA · Traditional | Remington Medical, Inc. | 02/25/1993SE |
| K922899 | Model 4280 Surgical Extension CableDSA · Traditional | Pace Medical | 12/23/1992SE |
| K910645 | Disposable Patient CableDSA · Traditional | Diag Corp. | 05/07/1991SE |
| K901780 | RTM 36-05, 60-05, RTD 36-05, 60-05 Radio. LeadwireDSA · Traditional | Medtronic Vascular | 10/09/1990SE |
| K894981 | Medtronic Model 5455S Disposable Surgical CableDSA · Traditional | Medtronic Vascular | 09/20/1989SE |
| K885137 | Astro Trace (Model AT-02)DSA · Traditional | The LE Blanc Corp. | 03/15/1989SE |
| K884592 | Astro Trace (Model AT-01)DSA · Traditional | The LE Blanc Corp. | 03/02/1989SE |
| K885101 | Medtronic Model 5411B Surgical Cable AdaptorDSA · Traditional | Medtronic Vascular | 01/12/1989SE |
| K882174 | Modified Model 5455 Disposable Surgical CableDSA · Traditional | Medtronic Andover Medical, Inc. | 07/22/1988SE |
| K880323 | Medtronic Model 5411 Surgical Cable AdaptorDSA · Traditional | Medtronic Vascular | 03/22/1988SE |
| K880320 | Electrode CableDSA · Traditional | Vital Connections, Inc. | 03/22/1988SE |
| K873492 | BSK-1033 Telemetry Monitoring CableDSA · Traditional | Desco Industries, Inc. | 10/09/1987SE |
| K820268 | Adaptaid Temp. Pacing Ext. Lead #366-02DSA · Traditional | Intermedics, Inc. | 03/26/1982SE |
| K802237 | Corrosion Proof Dual Purpose ECG WiresDSA · Traditional | Custom Cardio Components | 10/03/1980SE |
| K802236 | Corrosion Proof Snap ECG Connect WiresDSA · Traditional | Custom Cardio Components | 10/03/1980SE |
| K801041 | 3M R.F. Current SuppressorDSA · Traditional | 3M Company | 05/23/1980SE |
| K800932 | Ecg-Rf-Choke Cable-Adapter #'S 121,120DSA · Traditional | R2 Corp. | 05/23/1980SE |
| K800931 | R2(TM) ECG Cable-Adaptor #'S 120-121-122DSA · Traditional | R2 Corp. | 05/23/1980SE |
| K801064 | Disposable Patient Cable Model 5807DSA · Traditional | Daig Corp. | 05/14/1980SE |
| K771645 | Electrocardiographic Cablhs & Lead WireDSA · Traditional | Tronomed, Inc. | 10/18/1977SE |
| K771750 | RF Choke CableDSA · Traditional | C.R. Bard, Inc. | 09/30/1977SE |
| K771027 | Electrocardiographic Patient CablesDSA · Traditional | Tronomed, Inc. | 07/05/1977SE |
| K770884 | Elhctrocardiographic Connecting WiresDSA · Traditional | Tronomed, Inc. | 05/23/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1102-2025 Class II | LIFEPAK 35 ECG cable REF 11111-000041Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions | Physio-Control, Inc. | 01/21/2025Open, Classified |
| Z-0917-2022 Class III | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers:…Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become… | Volcano Corp | 02/03/2022Open, Classified |
| Z-2553-2019 Class II | Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24"…The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm. | GN Otometrics | 08/01/2019Open, Classified |
| Z-2495-2019 Class II | Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage:…The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified.… | Philips North America, LLC | 07/19/2019Terminated |
| Z-1879-2019 Class III | Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101…ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation… | GE Healthcare, LLC | 05/10/2019Terminated |
| Z-1878-2019 Class III | Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire…ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation… | GE Healthcare, LLC | 05/10/2019Terminated |
| Z-1877-2019 Class III | Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005…ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation… | GE Healthcare, LLC | 05/10/2019Terminated |
| Z-1876-2019 Class III | ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead…ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation… | GE Healthcare, LLC | 05/10/2019Terminated |
| Z-1875-2019 Class III | ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead…ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation… | GE Healthcare, LLC | 05/10/2019Terminated |
| Z-1441-2014 Class II | FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical…Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the… | Remington Medical Inc. | 03/05/2014Terminated |
| Z-0884-2011 | CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18…When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may… | Biosense Webster, Inc. | 10/05/2010Terminated |
| Z-2223-2010 | Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington…The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG. | Remington Medical Inc. | 05/19/2010Terminated |