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medtronic model 5513 endocardial pacing lead
Medtronic Vascular
Summary: The Medtronic Model 5513 Endocardial Pacing Lead is a cardiac device used to deliver electrical impulses to the heart. It's primarily used by cardiologists in patients requiring pacing therapy.
FDA Clearance Information
Pathway
510K
Number
K870885 ↗
Decision Date
November 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 5513 Endocardial Pacing Lead was cleared through the FDA 510(k) pathway on November 6, 1987. Manufactured by Medtronic Vascular, it is classified as a Class III device.
What It Is
The Medtronic Model 5513 Endocardial Pacing Lead is a specialized lead used in cardiac pacing systems. It is designed to be implanted within the heart's endocardial surface to deliver electrical impulses that regulate heartbeats. This lead is an integral component of pacemaker systems, ensuring proper cardiac rhythm management in patients with arrhythmias.
Clinical Applications
This pacing lead is commonly used in the management of bradycardia and other arrhythmias where pacing support is necessary. It is typically utilized in cardiology and electrophysiology settings, particularly in hospitals and specialized cardiac centers. Patients who benefit from this device often include those with heart block or sick sinus syndrome.
Indications for Use
The device is indicated for patients requiring electrical pacing of the heart due to conditions like bradycardia. It is suitable for individuals who have experienced heart block or other rhythm disturbances that necessitate pacing intervention.
Practical Considerations
The Medtronic Model 5513 is available in various lengths to accommodate different patient anatomies. It is compatible with Medtronic pacemaker generators and requires careful implantation technique to ensure optimal performance and longevity.
Frequently Asked Questions
What is the Medtronic Model 5513 Endocardial Pacing Lead used for?
It is used to deliver electrical impulses to the heart in patients requiring pacing therapy, such as those with bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital and specialized cardiac care settings.
What are the FDA-cleared indications?
It is indicated for patients needing electrical pacing of the heart due to conditions like bradycardia 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.