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slimline unipolar endocardial pacing lead 030-438
Telectronics
Summary: The slimline unipolar endocardial pacing lead by Telectronics is a medical device used for cardiac pacing. It is primarily utilized by cardiologists in settings requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K865098 ↗
Decision Date
August 18, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on August 18, 1987. Manufactured by Telectronics, it is classified as a Class III device under product code DTB.
What It Is
The slimline unipolar endocardial pacing lead is a specialized wire that delivers electrical impulses to the heart muscle to maintain an adequate heart rate. It is designed to be implanted inside the heart, with one end connected to a pacemaker and the other end in contact with the heart tissue. This device is crucial for patients with arrhythmias who require consistent cardiac pacing.
Clinical Applications
This pacing lead is commonly used in cardiac electrophysiology and cardiology settings. It is typically employed during procedures to implant pacemakers in patients with bradycardia or other rhythm disorders. The device is suitable for adult patients who require long-term pacing solutions and is often used in hospitals and specialized cardiac care centers.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing due to conditions like bradycardia. It is used to ensure that the heart maintains a regular rhythm, especially in individuals with slow heart rates.
Practical Considerations
The slimline design of the lead allows for easier implantation and compatibility with various pacemaker models. Clinicians should be aware of the lead's unipolar configuration, which may influence the choice of pacemaker and implantation technique. Proper sizing and placement are crucial for optimal performance.
Frequently Asked Questions
What is the slimline unipolar endocardial pacing lead used for?
It is used for cardiac pacing to manage arrhythmias, particularly in patients with bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradycardia.
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.