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laserdish silicone ventricular lead w trailing tin
Telectronics Pacing Systems
Summary: The Laserdish Silicone Ventricular Lead is a cardiac pacing lead used in patients requiring ventricular pacing. It is typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K903221 ↗
Decision Date
November 8, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Laserdish Silicone Ventricular Lead was cleared via the FDA 510k pathway on November 8, 1990. It is manufactured by Telectronics Pacing Systems and classified as a Class III device.
What It Is
The Laserdish Silicone Ventricular Lead is a medical device designed for cardiac pacing. It is a silicone-based lead with a trailing tin component, used to deliver electrical impulses to the heart's ventricles. This device is crucial for patients with arrhythmias or heart block, ensuring proper heart rhythm and function.
Clinical Applications
This ventricular lead is commonly used in procedures involving the implantation of pacemakers or defibrillators. Cardiologists and electrophysiologists use it in hospital settings, particularly in patients with bradycardia or heart block. It is essential for maintaining adequate heart rate and rhythm in patients with compromised cardiac conduction systems.
Indications for Use
The device is indicated for patients who require ventricular pacing due to conditions like bradycardia or heart block. It helps maintain a regular heart rhythm in individuals whose hearts cannot do so naturally.
Practical Considerations
The lead is typically available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker and defibrillator systems. Proper technique during implantation is crucial to ensure optimal lead placement and function.
Frequently Asked Questions
What is the Laserdish Silicone Ventricular Lead used for?
It is used for ventricular pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring ventricular pacing 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.