đź“‹ FDA Reference
cordis permanent pervenous cardiac leads
Cordis
Summary: Cordis Permanent Pervenous Cardiac Leads are used in cardiac pacing systems to deliver electrical impulses to the heart. Primarily used by cardiologists, these leads are crucial in managing patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K791768 ↗
Decision Date
November 5, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cordis Permanent Pervenous Cardiac Leads were cleared through the FDA 510(k) pathway on November 5, 1979. Manufactured by Cordis, this device is classified as Class 3 under product code DTB.
What It Is
Cordis Permanent Pervenous Cardiac Leads are medical devices designed to be implanted into the heart's venous system to provide electrical stimulation for cardiac pacing. These leads are integral components of pacemaker systems, ensuring the heart maintains an adequate rhythm. The leads are typically inserted through a vein and positioned in the heart to deliver electrical impulses effectively.
Clinical Applications
These cardiac leads are commonly used in patients with bradycardia or other arrhythmias requiring pacing. They are typically utilized in cardiology and electrophysiology settings. Patients who have experienced heart block or have a history of syncope due to slow heart rates are typical candidates for this device.
Indications for Use
The Cordis Permanent Pervenous Cardiac Leads are indicated for patients who require permanent cardiac pacing due to conditions like bradycardia or heart block. These leads help maintain a regular heart rhythm by delivering electrical impulses.
Practical Considerations
When considering these leads, clinicians should be aware of the typical sizes and configurations available to ensure compatibility with the chosen pacemaker system. Proper technique during insertion is crucial to avoid complications such as lead dislodgement or venous perforation.
Frequently Asked Questions
What is Cordis Permanent Pervenous Cardiac Leads used for?
These leads are used for delivering electrical impulses to the heart in patients requiring permanent cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in the management of arrhythmias.
What are the FDA-cleared indications?
The leads are indicated for patients needing permanent cardiac pacing, such as those with bradycardia 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.