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510(k) K163316

Device
Multi-Link X2 ECG Adapter And Direct Connect Lead Wire System
Applicant
CAREFUSION 303, INC.
510(k) number
K163316
Product code
DSA  
Decision
Substantially Equivalent (SESE)
Decision date
2017-06-22
Date received
2016-11-23
Regulation
870.2900
Classification name
Cable, Transducer And Electrode, Patient, (including Connector)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Erika Fernandez
Address
75 N Fairway Dr. Vernon Hills IL US 60061 60061

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254114Baylis Connector CableBaylis Medical Technologies, Inc.2026-01-18
K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)Drägerwerk AG & Co. KGaA2025-12-01
K251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapterShanghai Draeger Medical Instrument Co., Ltd.2025-09-30
K242986SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.2025-05-02
K243545Philips 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, SnPhilips Medizin Systeme Böblingen GmbH2025-01-17
K240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc.2024-09-13
K240377LIFEPAK® ECG CablesStryker Physio-Control2024-05-07
K240156LIFEPAK® 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)Physio-Control, Inc.2024-04-30
K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.2023-11-22
K230571RFP-100A Connector Cable (Single Use)Baylis Medical Technologies, Inc.2023-05-30
K222370SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.2023-04-02
K220447Med-link Disposable ECG Cable and LeadwiresShenzhen Med-Link Electronics Tech Co., Ltd.2022-06-28
K2119419LineEnergetic Designs, Inc.2022-01-27
K211294Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc.2021-08-16
K203556Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient CablesMedtronic, Inc.2021-07-12

Legacy Summary#

summary

FDA Review#

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