đź“‹ FDA Reference
pacing leads focus t81 t81f t82f t83 t83f t84f
Ela Medical
Summary: The pacing leads focus T81-T84F by Ela Medical are used in cardiac pacing systems to deliver electrical impulses to the heart. They are primarily used by cardiologists in settings such as hospitals and specialized cardiac care centers.
FDA Clearance Information
Pathway
510K
Number
K884394 ↗
Decision Date
December 8, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacing leads focus T81-T84F were cleared through the FDA 510k pathway on December 8, 1988, by Ela Medical. They are classified as Class III medical devices under product code DTB.
What It Is
These pacing leads are components of cardiac pacemaker systems, designed to transmit electrical impulses from the pacemaker to the heart muscle. They are crucial for maintaining adequate heart rhythm in patients with arrhythmias. The leads are typically inserted transvenously and positioned in the heart chambers, where they sense cardiac activity and deliver pacing as needed.
Clinical Applications
Pacing leads are commonly used in the treatment of bradycardia, heart block, and other rhythm disorders. Cardiologists and electrophysiologists implant these leads during pacemaker insertion procedures, often performed in hospital catheterization labs or specialized cardiac units. They are suitable for a wide range of patients, including those with chronic heart conditions or post-cardiac surgery.
Indications for Use
These pacing leads are indicated for patients requiring cardiac pacing due to conditions like slow heart rates or heart block. They help ensure the heart maintains a proper rhythm and rate, improving cardiac output and patient quality of life.
Practical Considerations
When selecting pacing leads, clinicians should consider the lead's length and compatibility with the pacemaker device. Proper technique during insertion is crucial to avoid complications such as lead dislodgement or perforation. Regular follow-up is necessary to monitor lead function and patient response.
Frequently Asked Questions
What is pacing leads focus T81-T84F used for?
These leads are used in cardiac pacing systems to manage heart rhythm disorders by delivering electrical impulses to the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in hospital and specialized cardiac care settings.
What are the FDA-cleared indications?
These leads are 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.