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
K801041 3M COMPANY 3M R.F. CURRENT SUPPRESSOR 05/23/1980
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
K940323 ARBO MEDICAL, INC. ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM 04/12/1995
K940302 ARBO MEDICAL, INC. ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM 11/30/1994
K940322 ARBO MEDICAL, INC. ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE 11/28/1994
K023334 BAYLIS MEDICAL CO., INC. BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 12/31/2002
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
K771750 C.R. BARD, INC. RF CHOKE CABLE 09/30/1977
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
K941839 CONMED ANDOVER MEDICAL, INC. DISPOSABLE SURGICAL CABLE 07/27/1994
K933649 CONMED CORP. CONMED ECG PATIENT CABLES AND LEADWIRES 02/18/1994
K945034 CONMED CORP. CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES 10/27/1994
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
K802237 CUSTOM CARDIO COMPONENTS CORROSION PROOF DUAL PURPOSE ECG WIRES 10/03/1980
K802236 CUSTOM CARDIO COMPONENTS CORROSION PROOF SNAP ECG CONNECT WIRES 10/03/1980
K801064 DAIG CORP. DISPOSABLE PATIENT CABLE MODEL 5807 05/14/1980
K043572 DATEX-OHMEDA COMPATIBILITY ECG TRUNK CABLES 02/22/2005
K873492 DESCO INDUSTRIES, INC. BSK-1033 TELEMETRY MONITORING CABLE 10/09/1987
K910645 DIAG CORP. DISPOSABLE PATIENT CABLE 05/07/1991
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
K820268 INTERMEDICS, INC. ADAPTAID TEMP. PACING EXT. LEAD #366-02 03/26/1982
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
K882174 MEDTRONIC ANDOVER MEDICAL, INC. MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE 07/22/1988
K880323 MEDTRONIC VASCULAR MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR 03/22/1988
K885101 MEDTRONIC VASCULAR MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR 01/12/1989
K894981 MEDTRONIC VASCULAR MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE 09/20/1989
K960446 MEDTRONIC VASCULAR MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES 05/22/1996
K901780 MEDTRONIC VASCULAR RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE 10/09/1990
K942321 MERIT CABLES INCORPORATED VARIOUSPATIENT MONITORING CABLE 11/04/1994
K954900 MINNESOTA MINING AND MFG. CO. 3M RED DOT ECG LEAD WIRES A 07/15/1996
K012392 PACE MEDICAL DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 09/04/2001
K922899 PACE MEDICAL MODEL 4280 SURGICAL EXTENSION CABLE 12/23/1992
K110287 PHILIPS MEDICAL SYSTEMS PHILIPS ECG LEADWIRE SET 02/15/2011
K941058 PROFESSIONAL CATHETER CORP. PROCATH PACING THRESHOLD CABLE 07/11/1994
K800932 R2 CORP. ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 05/23/1980
K800931 R2 CORP. R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 05/23/1980
K922009 REMINGTON MEDICAL, INC. DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 02/25/1993
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
K933603 SENTRY MEDICAL PRODUCTS, INC. LEADWIRE 01/18/1994
K932704 SENTRY MEDICAL PRODUCTS, INC. PATIENT CABLE 12/27/1993
K153188 SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. Caremed patient cable and leadwires 10/24/2016
K172797 Shenzhen Coreray Technology., Ltd ECG Cable/Leadwires 02/28/2018
K120010 SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) 01/19/2012
K093858 ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A 04/02/2010
K884592 THE LE BLANC CORP. ASTRO TRACE (MODEL AT-01) 03/02/1989
K885137 THE LE BLANC CORP. ASTRO TRACE (MODEL AT-02) 03/15/1989
K152947 TIGER MEDICAL PRODUCTS Disposable Temporary Pacing Cable 04/05/2016
K771645 TRONOMED, INC. ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE 10/18/1977
K771027 TRONOMED, INC. ELECTROCARDIOGRAPHIC PATIENT CABLES 07/05/1977
K770884 TRONOMED, INC. ELHCTROCARDIOGRAPHIC CONNECTING WIRES 05/23/1977
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
K880320 VITAL CONNECTIONS, INC. ELECTRODE CABLE 03/22/1988


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