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endocardial leads 414s 515s
Siemens Elema Ab
Summary: Endocardial leads 414s 515s are used in cardiac pacing systems to deliver electrical impulses to the heart. They are primarily used by cardiologists in hospital settings for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K802816 ↗
Decision Date
January 16, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial leads 414s 515s by Siemens Elema Ab were cleared through the FDA 510k pathway on January 16, 1981. They are classified as Class III devices under product code DTB.
What It Is
Endocardial leads 414s 515s are components of cardiac pacing systems, designed to transmit electrical impulses from a pacemaker to the heart muscle. These leads are inserted into the heart's chambers, typically the right atrium or ventricle, and are crucial for maintaining appropriate heart rhythms in patients with arrhythmias. The leads are designed to be flexible and durable, ensuring long-term functionality within the cardiac environment.
Clinical Applications
These endocardial leads are commonly used in procedures involving the implantation of pacemakers or defibrillators. Cardiologists and electrophysiologists typically perform these procedures in hospital settings, particularly in cardiac catheterization labs or operating rooms. The device is used for patients with bradycardia, heart block, or other rhythm disorders that necessitate electrical pacing support.
Indications for Use
The FDA indications suggest these leads are for patients who require cardiac pacing due to conditions like arrhythmias or heart block. They are suitable for individuals who need long-term rhythm management to maintain adequate cardiac output.
Practical Considerations
When using endocardial leads, clinicians should consider the appropriate lead length and diameter to ensure compatibility with the patient's anatomy and the pacing device. Proper technique during insertion is crucial to prevent complications such as lead dislodgement or cardiac perforation.
Frequently Asked Questions
What is endocardial leads 414s 515s used for?
They are used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in hospital settings.
What are the FDA-cleared indications?
They are indicated for patients needing cardiac pacing due to arrhythmias or heart block.
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.