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endocard pacing lead std length pl202
Daig
Summary: The Endocard Pacing Lead Std Length PL202 by Daig is a cardiac pacing lead used in cardiac rhythm management. It is typically used by cardiologists in procedures to manage arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K800350 ↗
Decision Date
May 28, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Endocard Pacing Lead Std Length PL202 was cleared through the FDA 510k pathway on May 28, 1980. Manufactured by Daig, it is classified as a Class 3 device under product code DTB.
What It Is
The Endocard Pacing Lead Std Length PL202 is a medical device used in 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 implanted in the heart and connected to a pacemaker, which regulates the heart's rhythm. This device is crucial for patients with bradycardia or heart block.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology labs. It is utilized during procedures to implant pacemakers in patients with slow heart rhythms or heart blocks. The device is suitable for adult patients who require long-term cardiac pacing. It is often used in hospital settings, including operating rooms and cardiac catheterization labs.
Indications for Use
The FDA indications for this device include use in patients with symptomatic bradycardia or heart block. It is intended for those who require electrical pacing to maintain an adequate heart rate.
Practical Considerations
The standard length of the lead is designed to accommodate typical adult anatomy. It is compatible with most pacemaker generators. Clinicians should ensure proper placement and secure fixation to prevent lead dislodgement.
Frequently Asked Questions
What is the Endocard Pacing Lead Std Length PL202 used for?
It is used for cardiac pacing to manage arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients with symptomatic bradycardia or heart block requiring pacing.
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.