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lifeline pacing lead model 465-01
Intermedics
Summary: The Lifeline Pacing Lead Model 465-01 is a cardiac pacing lead used in pacemaker systems to manage heart rhythm disorders. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K781497 ↗
Decision Date
February 1, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Pacing Lead Model 465-01 was cleared through the FDA 510(k) pathway on February 1, 1979, by Intermedics. It is classified as a Class III medical device under product code DTB.
What It Is
The Lifeline Pacing Lead Model 465-01 is a specialized wire that connects a pacemaker to the heart muscle, enabling electrical impulses to regulate heartbeats. It is designed to be implanted within the heart's chambers, ensuring reliable cardiac pacing. The lead is a critical component in pacemaker systems, providing the necessary interface for electrical conduction.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemaker systems, particularly for patients with bradycardia or other rhythm disorders. Cardiologists and electrophysiologists typically use this device in hospital cardiac units or specialized cardiac centers. It is suitable for adult and elderly patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is used in individuals who require consistent heart rate management.
Practical Considerations
The Lifeline Pacing Lead Model 465-01 is typically compatible with various pacemaker generators. Clinicians should ensure proper sizing and placement technique to optimize performance and minimize complications. Regular follow-up is necessary to monitor lead function and patient response.
Frequently Asked Questions
What is Lifeline Pacing Lead Model 465-01 used for?
It is used for cardiac pacing in patients with heart rhythm disorders, such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
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.