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pacing lead model 1188t
Siemens-Pacesetter
Summary: The pacing lead model 1188t by Siemens-Pacesetter is a medical device used for cardiac pacing. It is typically used by cardiologists to manage arrhythmias in patients requiring pacemaker therapy.
FDA Clearance Information
Pathway
510K
Number
K925038 ↗
Decision Date
July 15, 1994
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacing lead model 1188t was cleared through the FDA 510k pathway on July 15, 1994. It is manufactured by Siemens-Pacesetter and classified as a Class III device under product code DTB.
What It Is
The pacing lead model 1188t is a component of a cardiac pacemaker system, designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. It is implanted into the heart and connected to a pacemaker generator, helping to manage arrhythmias by ensuring the heart beats at a regular pace. This device is crucial for patients with bradycardia or other conditions that result in an abnormally slow heart rate.
Clinical Applications
This pacing lead is commonly used in cardiac electrophysiology and cardiology settings, particularly in hospitals and specialized cardiac centers. It is used in procedures involving the implantation of pacemakers in patients with symptomatic bradycardia, heart block, or other conduction disorders. The device is suitable for adult and pediatric populations requiring long-term pacing support.
Indications for Use
The pacing lead model 1188t is indicated for patients who require electrical pacing of the heart due to conditions like bradycardia or heart block. It is used to ensure that the heart maintains an adequate rate and rhythm, preventing symptoms like dizziness or syncope.
Practical Considerations
When considering the use of this pacing lead, clinicians should be aware of its compatibility with various pacemaker generators. Proper sizing and positioning during implantation are crucial for optimal performance and patient outcomes. Familiarity with the implantation technique is essential for successful use.
Frequently Asked Questions
What is pacing lead model 1188t 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 cardiac care settings.
What are the FDA-cleared indications?
The device 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.