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slimline unipolar endocardial pacing lead 30-407
Telectronics
Summary: The Slimline Unipolar Endocardial Pacing Lead 30-407 is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K853223 ↗
Decision Date
September 17, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Slimline Unipolar Endocardial Pacing Lead 30-407 was cleared via the FDA 510k pathway on September 17, 1985. Manufactured by Telectronics, it is classified as a Class III device.
What It Is
This device is an endocardial pacing lead designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. It is unipolar, meaning it has a single electrode that contacts the heart tissue. The lead is typically inserted through a vein and positioned within the heart under fluoroscopic guidance.
Clinical Applications
The Slimline Unipolar Endocardial Pacing Lead is commonly used in patients with bradycardia or other conduction disorders requiring pacing. It is typically utilized in cardiology and electrophysiology settings, often in hospital catheterization labs or specialized cardiac centers. The device is suitable for adult patients who need temporary or permanent pacing.
Indications for Use
This device is indicated for patients who require cardiac pacing due to conditions like bradycardia, heart block, or other rhythm disturbances. It is used to ensure the heart maintains an appropriate rate and rhythm.
Practical Considerations
The lead is designed to be compatible with a variety of pacemakers. Clinicians should ensure proper sizing and positioning during implantation to optimize performance. Familiarity with fluoroscopic techniques is essential for correct placement.
Frequently Asked Questions
What is the Slimline Unipolar Endocardial Pacing Lead 30-407 used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to rhythm disturbances such as 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.