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endocardial screw-in lead model 1020t
Pacesetter Systems
Summary: The endocardial screw-in lead model 1020t is a cardiac device used in pacing therapies. It is primarily used by cardiologists to manage arrhythmias in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K895447 ↗
Decision Date
December 20, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial screw-in lead model 1020t was cleared through the FDA 510(k) pathway on December 20, 1989. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The endocardial screw-in lead model 1020t is a type of cardiac lead used in pacemaker systems. It is designed to be implanted into the heart's endocardial surface, where it delivers electrical impulses to maintain a regular heart rhythm. The screw-in mechanism ensures stable fixation to the heart tissue, reducing the risk of lead dislodgement.
Clinical Applications
This device is commonly used in procedures where a pacemaker is indicated, such as in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically implant these leads in hospital settings, particularly in cardiac catheterization labs. It is suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The device is indicated for patients who need cardiac pacing due to conditions like slow heart rates or heart block. It helps maintain adequate heart rhythm and function in these patients.
Practical Considerations
The lead is typically available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Proper technique during implantation is crucial to ensure stable fixation and optimal pacing performance.
Frequently Asked Questions
What is the endocardial screw-in lead model 1020t used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like slow heart rates 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.