BEUDAMED
    Product Code: DSA FDA class 2 21 CFR 870.2900

    Cable, Transducer And Electrode, Patient, (Including Connector)

    Cardiovascular

    The Patient Transducer and Electrode Cable (including Connector) is a cardiovascular accessory device used to connect patient electrodes or transducers to monitoring, recording, or diagnostic equipment, transmitting physiological signals with minimal interference. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSA and it is regulated under 21 CFR 870.2900 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    102
    FEI Numbers
    130
    Registration Numbers
    130
    Unique Applicants
    77
    Years Active
    48

    Basic Information

    Product Code
    DSA
    Device Class
    FDA class 2
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 102 510(k) clearances via K numbers.

    K Number Device Name
    K242986 SpO2 Extension Cable
    K243545 Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn
    K240087 RT Carbon ECG Leads
    K240377 LIFEPAK® ECG Cables
    K240156 LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)
    K222712 Fogg System Patient Monitoring Cables
    K230571 RFP-100A Connector Cable (Single Use)
    K222370 SpO2 Extension Cable
    K220447 Med-link Disposable ECG Cable and Leadwires
    K211941 9Line
    K211294 Multi-Link X2 ECG Cable and Leadwire System
    K203556 Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
    K200722 PCA-C1 series Patient Cable
    K203635 Patient Monitoring Cables
    K200510 Multi-LinkTM X2 ECG Adapter and Leadwires
    K201359 ECG Cables and Leadwires
    K200674 AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
    K192404 Patient Monitoring Cable (SpO2 Extension Cable)
    K200026 Disposable ECG Cable
    K181089 SureLead Cable System
    K191428 ECG Cable
    K191273 Multi-Link X2 ECG and SpO2 Adapter
    K190078 IntraSight
    K182327 Patient Cables and Leadwires , Disposable ECG Leadwires
    K182220 Curbell branded Patient Monitoring Cables
    K181726 Medline Patient Cables and Lead Wires
    K172797 ECG Cable/Leadwires
    K172591 Fixed Patient Leads ECG Cable (Model 3153)
    K162768 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
    K163316 Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
    K170536 ECG Disposable Lead Wire
    K162432 Multi-Link X2 ECG Cable and Lead Wire System
    K153188 Caremed patient cable and leadwires
    K152947 Disposable Temporary Pacing Cable
    K142489 Unimed Disposable ECG lead wires
    K132253 REMOVABLE PATIENT LEADS ECG CABLE
    K120010 CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
    K110287 PHILIPS ECG LEADWIRE SET
    K102430 TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
    K101660 ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
    K093858 PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
    K093657 ADAGIO RETRACTING ECG LEAD WIRES
    K082851 MULTLINK CABLE AND LEADWIRE SYSTEM
    K082959 PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
    K081762 CURBELL PATIENT MONITORING CABLES
    K080112 PATIENT CABLE
    K080605 SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
    K080621 FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
    K071751 LIFESYNC ADAPTER, MODEL LS-302
    K070232 ECG CABLES, TRUNK AND PATIENT LEAD WIRES
    K062577 V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
    K043572 COMPATIBILITY ECG TRUNK CABLES
    K030005 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES
    K023334 BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
    K022075 DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
    K013598 REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES
    K012392 DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
    K010809 BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000
    K002781 MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS
    K001390 BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
    K992524 PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
    K984263 EWC: ECG II CABLE LEADWIRE SYSTEM
    K982817 EWC: ECG CABLE AND LEADWIRE SYSTEMS
    K980806 AFFINITY MEDICAL PATIENT CABLE SYSTEM
    K980582 MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
    K971968 SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
    K954900 3M RED DOT ECG LEAD WIRES A
    K960446 MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
    K952659 TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
    K940323 ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM
    K940302 ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM
    K940322 ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE
    K942321 VARIOUSPATIENT MONITORING CABLE
    K945034 CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES
    K941839 DISPOSABLE SURGICAL CABLE
    K941058 PROCATH PACING THRESHOLD CABLE
    K933649 CONMED ECG PATIENT CABLES AND LEADWIRES
    K933603 LEADWIRE
    K932704 PATIENT CABLE
    K922009 DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
    K922899 MODEL 4280 SURGICAL EXTENSION CABLE
    K910645 DISPOSABLE PATIENT CABLE
    K901780 RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE
    K894981 MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE
    K885137 ASTRO TRACE (MODEL AT-02)
    K884592 ASTRO TRACE (MODEL AT-01)
    K885101 MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
    K882174 MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE
    K880323 MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
    K880320 ELECTRODE CABLE
    K873492 BSK-1033 TELEMETRY MONITORING CABLE
    K820268 ADAPTAID TEMP. PACING EXT. LEAD #366-02
    K802237 CORROSION PROOF DUAL PURPOSE ECG WIRES
    K802236 CORROSION PROOF SNAP ECG CONNECT WIRES
    K801041 3M R.F. CURRENT SUPPRESSOR
    K800932 ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120
    K800931 R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122
    K801064 DISPOSABLE PATIENT CABLE MODEL 5807
    K771645 ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE
    K771750 RF CHOKE CABLE
    K771027 ELECTROCARDIOGRAPHIC PATIENT CABLES
    K770884 ELHCTROCARDIOGRAPHIC CONNECTING WIRES

    FEI Numbers

    This FDA classification entry is associated with 130 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 130 registration numbers. Click on an entry to view related FDA registrations.