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modified models 1025m 1026t pacing lead
Pacesetter Systems
Summary: The modified models 1025m and 1026t pacing leads are used in cardiac pacing procedures to deliver electrical impulses to the heart. They are primarily used by cardiologists in settings such as hospitals and specialized cardiac centers.
FDA Clearance Information
Pathway
510K
Number
K873931 ↗
Decision Date
October 22, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The modified models 1025m and 1026t pacing leads were cleared through the FDA 510k pathway on October 22, 1987. Manufactured by Pacesetter Systems, these devices are classified as Class III under product code DTB.
What It Is
These pacing leads are medical devices designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with bradycardia or other cardiac rhythm disorders. They are typically inserted via a transvenous approach and connected to a pacemaker. The leads are insulated wires that transmit electrical signals from the pacemaker to the heart muscle.
Clinical Applications
Pacing leads like the modified models 1025m and 1026t are commonly used in procedures involving the implantation of pacemakers. They are utilized by cardiologists and electrophysiologists in hospital settings, particularly in cardiac catheterization labs. These devices are essential for patients with conditions such as heart block or sick sinus syndrome, where maintaining a regular heart rhythm is crucial.
Indications for Use
The FDA indications suggest these pacing leads are intended for patients who require cardiac pacing due to conditions like bradycardia. They are suitable for individuals with heart rhythm disorders that necessitate the use of a pacemaker to ensure proper cardiac function.
Practical Considerations
When considering these pacing leads, clinicians should be aware of the typical sizing and compatibility with various pacemaker models. Proper technique during insertion is crucial to ensure optimal lead placement and function. Compatibility with the patient's anatomy and the specific pacemaker system being used should be evaluated.
Frequently Asked Questions
What is modified models 1025m 1026t pacing lead used for?
These pacing leads are used to deliver electrical impulses to the heart in patients requiring cardiac pacing due to rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in cardiac pacing procedures.
What are the FDA-cleared indications?
The pacing leads are indicated for patients with conditions like bradycardia that require cardiac pacing to maintain proper heart rhythm.
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.