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changes to encor pervenous j-atrial leads
Cordis Leads
Summary: The Encor Pervenous J-Atrial Leads are used in cardiac pacing systems to facilitate electrical conduction in patients with arrhythmias. They are typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K873772 ↗
Decision Date
October 19, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Encor Pervenous J-Atrial Leads were cleared through the FDA 510k pathway on October 19, 1988. Manufactured by Cordis Leads, this device is classified as Class III under product code DTB.
What It Is
The Encor Pervenous J-Atrial Leads are specialized cardiac leads designed for use in pacing systems. These leads are inserted into the heart's atrium via the venous system to provide electrical stimulation for patients with arrhythmias. They are critical components in maintaining proper heart rhythm and are often used in conjunction with pacemakers.
Clinical Applications
These leads are commonly used in procedures involving the implantation of pacemakers, particularly for patients with atrial fibrillation or other atrial arrhythmias. Cardiologists and electrophysiologists in hospital settings typically perform these procedures. The device is suitable for adult patients who require long-term pacing solutions.
Indications for Use
The FDA indications suggest that this device is intended for patients who need electrical conduction support due to atrial arrhythmias. It is specifically designed for use in cardiac pacing systems to ensure proper heart rhythm.
Practical Considerations
The Encor Pervenous J-Atrial Leads come in various lengths and configurations to accommodate different patient anatomies. Compatibility with specific pacemaker models should be confirmed before use. Proper technique during insertion is crucial to avoid complications.
Frequently Asked Questions
What is Encor Pervenous J-Atrial Leads used for?
They are used to provide electrical conduction in cardiac pacing systems for patients with atrial arrhythmias.
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 needing electrical conduction support due to atrial arrhythmias.
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.