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endocard pacing lead long length pl200
Diag
Summary: The Endocard Pacing Lead Long Length PL200 by Diag is a cardiac pacing lead used in cardiac electrophysiology procedures. It is primarily used by cardiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K800349 ↗
Decision Date
May 28, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on May 28, 1980. It is manufactured by Diag and classified as a Class III device under product code DTB.
What It Is
The Endocard Pacing Lead Long Length PL200 is a specialized medical device used for cardiac pacing. It is designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias. The lead is typically inserted into the heart via a vein and positioned in the endocardium, where it can effectively stimulate the heart muscle.
Clinical Applications
This pacing lead is commonly used in procedures to treat bradycardia or other heart rhythm disorders. It is typically employed in hospital settings, particularly in cardiology departments, and is used by electrophysiologists and cardiologists. The device is suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest this device is intended for patients with heart rhythm disorders requiring pacing. It is particularly useful for those with slow heart rates or conduction system diseases.
Practical Considerations
The lead comes in various lengths to accommodate different patient anatomies and is compatible with most pacemaker generators. Proper technique during insertion is crucial to ensure optimal lead placement and function.
Frequently Asked Questions
What is the Endocard Pacing Lead Long Length PL200 used for?
It is used for cardiac pacing in patients with arrhythmias, particularly those with bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for patients with heart rhythm disorders that require pacing, such as bradycardia.
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.