FDA 510(k) Applications for Medical Device Product Code "DSA"
(Cable, Transducer And Electrode, Patient, (Including Connector))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K093657 | ACIST MEDICAL SYSTEMS, INC. | ADAGIO RETRACTING ECG LEAD WIRES | 01/15/2010 |
| K992524 | ADVANTAGE MEDICAL ELECTRONICS, INC. | PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES | 03/01/2000 |
| K980806 | AFFINITY MEDICAL TECHNOLOGIES, LLC. | AFFINITY MEDICAL PATIENT CABLE SYSTEM | 03/25/1998 |
| K070232 | AMERICAN I.V. PRODUCTS, INC. | ECG CABLES, TRUNK AND PATIENT LEAD WIRES | 03/27/2007 |
| K170536 | APK Technology Co., Ltd. | ECG Disposable Lead Wire | 04/24/2017 |
| K200674 | Atrility Medical, LLC | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector | 07/02/2020 |
| K181089 | Authentic Medical | SureLead Cable System | 01/17/2020 |
| K023334 | BAYLIS MEDICAL CO., INC. | BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 | 12/31/2002 |
| K230571 | Baylis Medical Technologies Inc. | RFP-100A Connector Cable (Single Use) | 05/30/2023 |
| K222370 | Beijing Rongrui-Century Science & Technology Co., Ltd. | SpO2 Extension Cable | 04/02/2023 |
| K001390 | BIOSENSE WEBSTER, INC. | BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES | 07/21/2000 |
| K132253 | BOSTON SCIENTIFIC | REMOVABLE PATIENT LEADS ECG CABLE | 12/16/2013 |
| K172591 | Boston Scientific Corporation | Fixed Patient Leads ECG Cable (Model 3153) | 11/03/2017 |
| K013598 | C.R. BARD, INC. | REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES | 01/11/2002 |
| K162432 | CAREFUSION 2200 INC. | Multi-Link X2 ECG Cable and Lead Wire System | 01/18/2017 |
| K163316 | CAREFUSION 303, INC. | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | 06/22/2017 |
| K022075 | CP MEDICAL | DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 | 09/19/2002 |
| K081762 | CURBELL ELECTRONICS INC. | CURBELL PATIENT MONITORING CABLES | 08/27/2008 |
| K080605 | CURBELL ELECTRONICS INC. | SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL | 05/05/2008 |
| K182220 | Curbell Medical Products, Inc. | Curbell branded Patient Monitoring Cables | 11/07/2018 |
| K043572 | DATEX-OHMEDA | COMPATIBILITY ECG TRUNK CABLES | 02/22/2005 |
| K211941 | Energetic Designs, Inc. | 9Line | 01/27/2022 |
| K080621 | EUROPEAN CUSTOM MANUFACTURING BV | FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 | 04/29/2008 |
| K984263 | EWC | EWC: ECG II CABLE LEADWIRE SYSTEM | 02/02/1999 |
| K982817 | EWC | EWC: ECG CABLE AND LEADWIRE SYSTEMS | 09/23/1998 |
| K082851 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MULTLINK CABLE AND LEADWIRE SYSTEM | 11/19/2008 |
| K162768 | INTEGRAL PROCESS SAS | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables | 08/16/2017 |
| K203635 | JKH USA, LLC | Patient Monitoring Cables | 02/05/2021 |
| K101660 | KEPLER MEDTEC | ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 | 08/11/2010 |
| K071751 | LIFESYNC CORPORATION | LIFESYNC ADAPTER, MODEL LS-302 | 08/27/2007 |
| K980582 | MARQUETTE MEDICAL SYSTEMS, INC. | MULTI-LINK CABLE AND LEAD WIRE SYSTEMS | 03/16/1998 |
| K080112 | MED-DYNE | PATIENT CABLE | 06/20/2008 |
| K002781 | MEDICAL CABLES, INC. | MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS | 11/29/2000 |
| K181726 | Medline Industries, Inc. | Medline Patient Cables and Lead Wires | 09/20/2018 |
| K203556 | Medtronic , Inc. | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | 07/12/2021 |
| K960446 | MEDTRONIC VASCULAR | MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES | 05/22/1996 |
| K954900 | MINNESOTA MINING AND MFG. CO. | 3M RED DOT ECG LEAD WIRES A | 07/15/1996 |
| K182327 | Orantech Inc. | Patient Cables and Leadwires , Disposable ECG Leadwires | 01/30/2019 |
| K012392 | PACE MEDICAL | DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 | 09/04/2001 |
| K110287 | PHILIPS MEDICAL SYSTEMS | PHILIPS ECG LEADWIRE SET | 02/15/2011 |
| K200722 | QT Medical, Inc. | PCA-C1 series Patient Cable | 06/03/2021 |
| K971968 | REMINGTON MEDICAL, INC. | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) | 07/23/1997 |
| K010809 | RF INDUSTRIES, LTD. | BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000 | 05/23/2001 |
| K153188 | SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. | Caremed patient cable and leadwires | 10/24/2016 |
| K200026 | Shenzhen Changke Connect Electronics Co., Ltd. | Disposable ECG Cable | 05/12/2020 |
| K191428 | Shenzhen Changke Connect Electronics Co., Ltd. | ECG Cable | 11/27/2019 |
| K172797 | Shenzhen Coreray Technology., Ltd | ECG Cable/Leadwires | 02/28/2018 |
| K192404 | Shenzhen Coreray Technology., Ltd | Patient Monitoring Cable (SpO2 Extension Cable) | 06/22/2020 |
| K120010 | SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. | CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) | 01/19/2012 |
| K220447 | Shenzhen Med-link Electronics Tech Co., Ltd. | Med-link Disposable ECG Cable and Leadwires | 06/28/2022 |
| K093858 | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A | 04/02/2010 |
| K152947 | TIGER MEDICAL PRODUCTS | Disposable Temporary Pacing Cable | 04/05/2016 |
| K952659 | TRONOMED, INC. | TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM | 01/11/1996 |
| K102430 | TYCO ELECTRONICS CORPORATION | TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET | 09/10/2010 |
| K062577 | TZ MEDICAL, INC. | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC | 12/15/2006 |
| K082959 | UNIMED MEDICAL SUPPLIES INC. | PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS | 10/10/2008 |
| K142489 | UNIMED MEDICAL SUPPLIES INC. | Unimed Disposable ECG lead wires | 11/04/2014 |
| K030005 | VANGUARD MEDICAL CONCEPTS, INC. | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES | 03/18/2003 |
| K190078 | Volcano Corporation | IntraSight | 02/11/2019 |
| K191273 | Vyaire Medical, Inc. | Multi-Link X2 ECG and SpO2 Adapter | 09/13/2019 |
| K211294 | Vyaire Medical, Inc. | Multi-Link X2 ECG Cable and Leadwire System | 08/16/2021 |
| K200510 | Vyaire Medical, Inc. | Multi-LinkTM X2 ECG Adapter and Leadwires | 10/09/2020 |
| K201359 | Xinkang Medical Instrument Co., Ltd | ECG Cables and Leadwires | 10/01/2020 |
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