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lifeline pacing leads 471-07 09
Intermedics
Summary: The Lifeline Pacing Leads 471-07 09 by Intermedics are used in cardiac pacing procedures to maintain heart rhythm. They are primarily used by cardiologists in settings such as hospitals and cardiac care units.
FDA Clearance Information
Pathway
510K
Number
K832409 ↗
Decision Date
August 12, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Pacing Leads 471-07 09 were cleared by the FDA via the 510k pathway on August 12, 1983. Manufactured by Intermedics, this device is classified as Class 3 under product code DTB.
What It Is
The Lifeline Pacing Leads 471-07 09 are medical devices used in cardiac pacing systems to deliver electrical impulses to the heart. These leads are implanted into the heart tissue and connected to a pacemaker, which helps regulate the heart's rhythm. The device is crucial for patients with arrhythmias or heart block, ensuring consistent cardiac output.
Clinical Applications
These pacing leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically perform these procedures in hospital settings. The device is suitable for adult patients who require long-term pacing support to maintain adequate heart function.
Indications for Use
The FDA indications suggest that the Lifeline Pacing Leads are intended for patients with conditions that require cardiac pacing, such as those with symptomatic bradycardia or atrioventricular block. These leads help maintain an adequate heart rate and rhythm.
Practical Considerations
The Lifeline Pacing Leads come in various sizes to accommodate different patient anatomies. They are compatible with most pacemaker generators. Proper implantation technique is crucial to ensure optimal lead placement and function, typically requiring fluoroscopic guidance.
Frequently Asked Questions
What is Lifeline Pacing Leads 471-07 09 used for?
The device is used to deliver electrical impulses to the heart in patients requiring cardiac pacing, such as those with bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital and cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to conditions like symptomatic bradycardia or atrioventricular 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.