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permanent endocard unipolar tined lead
Diag
Summary: The permanent endocard unipolar tined lead is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring long-term cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K812905 ↗
Decision Date
February 4, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The permanent endocard unipolar tined lead was cleared through the FDA 510(k) pathway on February 4, 1982. Manufactured by Diag, it is a Class III medical device.
What It Is
This device is a unipolar tined lead designed for permanent implantation in the heart. It functions by delivering electrical impulses to stimulate heart contractions, ensuring proper cardiac rhythm. The tined design helps secure the lead in place within the heart tissue, reducing the risk of displacement.
Clinical Applications
The device is commonly used in the management of patients with bradycardia or other conditions requiring cardiac pacing. It is typically utilized in cardiology settings, including 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 FDA indications suggest this device is intended for patients needing permanent cardiac pacing. It is suitable for individuals with conditions that impair the heart's natural pacing ability.
Practical Considerations
Clinicians should consider the appropriate lead size and compatibility with the patient's anatomy and existing cardiac devices. Proper implantation technique is crucial to ensure lead stability and function.
Frequently Asked Questions
What is the permanent endocard unipolar tined lead used for?
It is used for permanent cardiac pacing in patients with conditions like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring permanent cardiac pacing due to impaired heart rhythm.
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.