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endocard pacin lead-long length pl200
Daig
Summary: The Endocard Pacing Lead-Long Length PL200 is a cardiac device used for pacing the heart. It is typically used by cardiologists in settings requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K771565 ↗
Decision Date
September 14, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Endocard Pacing Lead-Long Length PL200 by Daig was cleared through the FDA 510k pathway on September 14, 1977. It is classified as a Class 3 device under product code DTB.
What It Is
The Endocard Pacing Lead-Long Length PL200 is a specialized lead used in cardiac pacing systems. It delivers electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. This device is crucial for patients with arrhythmias or heart block, where natural cardiac pacing is insufficient.
Clinical Applications
This pacing lead is commonly used in electrophysiology and cardiology settings. It is essential in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. The device is suitable for adult patients who require long-term cardiac pacing support.
Indications for Use
The device is indicated for patients who need cardiac pacing due to conditions like bradycardia or heart block. It helps maintain an adequate heart rate when the heart's natural pacemaker is not functioning properly.
Practical Considerations
The lead is designed for compatibility with various pacemaker models. Clinicians should consider the lead's length and diameter to ensure proper fit and function within the patient's vasculature. Proper technique during implantation is crucial to avoid complications.
Frequently Asked Questions
What is the Endocard Pacing Lead-Long Length PL200 used for?
It is used for pacing the heart in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management.
What are the FDA-cleared indications?
The device is indicated for patients requiring 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.