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endocard pacin lead-std length pl100
Daig
Summary: The Endocard Pacing Lead-Std Length PL100 by Daig is a cardiac pacing lead used in patients requiring cardiac rhythm management. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K771564 ↗
Decision Date
September 14, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Endocard Pacing Lead-Std Length PL100 was cleared by the FDA through the 510(k) pathway on September 14, 1977. Manufactured by Daig, it is classified as a Class III device under product code DTB.
What It Is
The Endocard Pacing Lead-Std Length PL100 is a medical device designed for cardiac pacing. It is a flexible wire that connects a pacemaker to the heart, delivering electrical impulses to maintain an adequate heart rate. This device is crucial for patients with arrhythmias or heart block, ensuring proper cardiac function.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, often performed by cardiologists or electrophysiologists. It is utilized in hospital settings, particularly in cardiac catheterization labs or operating rooms. The device is suitable for adult patients with conditions like bradycardia or atrioventricular block.
Indications for Use
The device is indicated for patients who require cardiac pacing due to conditions such as slow heart rhythms or heart block. It is used to ensure the heart beats at a normal rate and rhythm.
Practical Considerations
The standard length of the lead should be considered when planning implantation to ensure proper fit and function. Compatibility with various pacemaker models is essential, and clinicians should be familiar with the implantation technique to minimize complications.
Frequently Asked Questions
What is Endocard Pacing Lead-Std Length PL100 used for?
It is used for cardiac pacing in patients with arrhythmias or heart block.
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 slow heart rhythms 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.