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philips ecg leadwire set
Philips Medical Systems
Summary: The Philips ECG Leadwire Set is a medical device used for monitoring cardiac activity. It is primarily used by cardiologists and healthcare professionals in hospital settings to obtain accurate ECG readings.
FDA Clearance Information
Pathway
510K
Number
K110287 ↗
Decision Date
February 15, 2011
Product Code
DSA
Device Class
Class 2
Evidence
419 studies
The Philips ECG Leadwire Set was cleared through the FDA 510(k) pathway on February 15, 2011. Manufactured by Philips Medical Systems, it is classified as a Class 2 device under product code DSA.
What It Is
The Philips ECG Leadwire Set is a component of an electrocardiogram (ECG) system, which is used to measure the electrical activity of the heart. It consists of leadwires that connect electrodes placed on the patient's skin to an ECG machine. This setup allows for the recording and monitoring of heart rhythms, aiding in the diagnosis and management of cardiac conditions.
Clinical Applications
This device is commonly used in cardiology, emergency medicine, and critical care settings. It is essential for procedures such as stress tests, continuous cardiac monitoring, and during surgeries where cardiac function needs to be closely observed. The device is suitable for a wide range of patient populations, including adults and pediatric patients, in both inpatient and outpatient settings.
Indications for Use
The FDA indications for the Philips ECG Leadwire Set involve its use in capturing and transmitting cardiac electrical signals for diagnostic purposes. It is intended for patients who require cardiac monitoring due to conditions like arrhythmias, myocardial infarction, or other heart-related issues.
Practical Considerations
The Philips ECG Leadwire Set is designed to be compatible with a variety of ECG machines. It is important to ensure proper lead placement and secure attachment to obtain accurate readings. The leadwires come in different lengths to accommodate various patient sizes and clinical settings.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Philips ECG Leadwire Set used for?
It is used for monitoring and recording the electrical activity of the heart in clinical settings.
What specialties typically use this device?
Cardiology, emergency medicine, and critical care specialists commonly use this device.
What are the FDA-cleared indications?
It is indicated for capturing and transmitting cardiac electrical signals for diagnostic purposes in patients with heart conditions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.