đź“‹ FDA Reference
pacesetter systems endocardial small fin lead
Pacesetter Systems
Summary: The Pacesetter Systems Endocardial Small Fin Lead is a cardiac pacing lead used in pacemaker implantation procedures. It is primarily utilized by cardiologists and electrophysiologists to manage patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K854405 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Pacesetter Systems Endocardial Small Fin Lead was cleared through the FDA 510(k) pathway on December 4, 1985. Manufactured by Pacesetter Systems, this device is classified as a Class III medical device.
What It Is
The Pacesetter Systems Endocardial Small Fin Lead is a specialized cardiac lead designed for use in pacemaker systems. It is inserted into the heart's endocardial surface to deliver electrical impulses that regulate heartbeats. The 'small fin' design aids in stable placement and reduces the risk of lead dislodgement, ensuring reliable pacing performance.
Clinical Applications
This lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically utilize this device in hospital settings. It is suitable for a wide range of patient populations, including those with chronic arrhythmias requiring long-term pacing support.
Indications for Use
The device is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. It helps maintain an adequate heart rate in patients whose natural pacemaker is not functioning properly.
Practical Considerations
The small fin design of the lead facilitates secure placement within the heart, minimizing the risk of dislodgement. It is compatible with various pacemaker models, and clinicians should ensure proper sizing and placement technique during implantation to optimize performance.
Frequently Asked Questions
What is Pacesetter Systems Endocardial Small Fin Lead used for?
It is used for delivering electrical impulses to the heart in patients requiring pacemaker support due to arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of cardiac arrhythmias.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac 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.