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endocar pacing lead-std length pl202
Daig
Summary: The Endocar Pacing Lead-Std Length PL202 is a cardiac pacing lead used in cardiac electrophysiology to deliver electrical impulses to the heart. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K771566 ↗
Decision Date
September 14, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Endocar Pacing Lead-Std Length PL202 was cleared through the FDA 510k pathway on September 14, 1977. Manufactured by Daig, it is classified as a Class 3 medical device.
What It Is
The Endocar Pacing Lead-Std Length PL202 is a medical device used to provide electrical pacing to the heart. It is designed to be implanted in the heart's chambers to help regulate heartbeats in patients with arrhythmias or other cardiac conditions. The lead connects to a pacemaker, transmitting electrical impulses that prompt the heart to beat at a normal rate.
Clinical Applications
This pacing lead is commonly used in procedures involving cardiac rhythm management, particularly in patients with bradycardia or heart block. It is typically utilized in cardiology and electrophysiology departments within hospitals. The device is suitable for adult patients requiring temporary or permanent pacing support.
Indications for Use
The FDA indications suggest this device is intended for patients who need cardiac pacing due to conditions like arrhythmias. It is used to ensure the heart maintains an adequate rhythm and rate.
Practical Considerations
The Endocar Pacing Lead-Std Length PL202 is designed to be compatible with standard pacemaker systems. Clinicians should be aware of the lead's length and ensure proper placement during implantation to avoid complications. Regular monitoring post-implantation is recommended to ensure device functionality.
Frequently Asked Questions
What is the Endocar Pacing Lead-Std Length PL202 used for?
It is used for cardiac pacing in patients with arrhythmias to help maintain a normal heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias 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.