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cordis pervenous atrial lead
Cordis
Summary: The Cordis Pervenous Atrial Lead is a medical device used in cardiac procedures to provide electrical stimulation to the heart. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K810432 ↗
Decision Date
March 13, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cordis Pervenous Atrial Lead was cleared through the FDA 510k pathway on March 13, 1981. Manufactured by Cordis, it is classified as a Class III device.
What It Is
The Cordis Pervenous Atrial Lead is an implantable device designed to deliver electrical impulses to the atrium of the heart. It is typically used in conjunction with a pacemaker system to manage arrhythmias. The lead is inserted through a vein and positioned in the atrium to ensure proper electrical conduction.
Clinical Applications
This device is commonly used in the management of atrial arrhythmias, such as atrial fibrillation or atrial flutter. It is often employed in electrophysiology labs during procedures to implant pacemakers or defibrillators. Patients who benefit from this device typically have conditions that affect the heart's electrical system, requiring regular monitoring and intervention.
Indications for Use
The FDA indications suggest that this device is intended for patients who require electrical stimulation of the heart due to arrhythmias. It is suitable for those with conditions that disrupt normal heart rhythm, necessitating the use of a pacemaker.
Practical Considerations
When using the Cordis Pervenous Atrial Lead, clinicians should be aware of the lead's compatibility with various pacemaker models. Proper placement and secure fixation are crucial for optimal performance. The lead is available in different lengths to accommodate patient anatomy.
Frequently Asked Questions
What is the Cordis Pervenous Atrial Lead used for?
It is used to deliver electrical impulses to the heart's atrium, primarily for managing 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 requiring electrical stimulation of the heart due to 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.