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model 486-02 endocardial pacing lead
Intermedics
Summary: The Model 486-02 Endocardial Pacing Lead is a cardiac device used to deliver electrical impulses to the heart muscle, ensuring proper heart rhythm. It is primarily used by cardiologists in patients requiring pacing therapy.
FDA Clearance Information
Pathway
510K
Number
K860547 ↗
Decision Date
June 13, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 486-02 Endocardial Pacing Lead was cleared through the FDA 510(k) pathway on June 13, 1986. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 486-02 Endocardial Pacing Lead is a specialized wire designed to be placed inside the heart's chambers to deliver electrical impulses from a pacemaker to the heart muscle. This device helps maintain an appropriate heart rate in patients with arrhythmias. It is typically inserted via a transvenous approach and positioned in the right atrium or ventricle.
Clinical Applications
This pacing lead is commonly used in cardiology for patients with bradycardia or heart block who require pacing to maintain adequate heart rates. It is utilized in hospital settings, particularly in cardiac catheterization labs or electrophysiology suites. The device is suitable for adult and pediatric patients who need chronic pacing therapy.
Indications for Use
The Model 486-02 is indicated for patients with conditions like symptomatic bradycardia, atrioventricular block, or other conduction disorders where pacing is necessary to maintain cardiac output.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most modern pacemakers. Proper lead placement and secure fixation are crucial for optimal performance and longevity of the device.
Frequently Asked Questions
What is the Model 486-02 Endocardial Pacing Lead used for?
It is used to deliver electrical impulses to the heart to maintain a proper heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists, especially those specializing in electrophysiology, use this device in clinical practice.
What are the FDA-cleared indications?
The device is indicated for patients with symptomatic bradycardia, atrioventricular block, or other conduction disorders requiring pacing.
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.