đź“‹ FDA Reference
cordis encor pervenous atrial ventricular leads
Cordis
Summary: The Cordis Encor Pervenous Atrial Ventricular Leads are used for cardiac pacing in patients with heart rhythm disorders. They are primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K844970 ↗
Decision Date
March 27, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cordis Encor Pervenous Atrial Ventricular Leads were cleared through the FDA 510k pathway on March 27, 1985. Manufactured by Cordis, this Class 3 device is used for cardiac pacing.
What It Is
The Cordis Encor Pervenous Atrial Ventricular Leads are medical devices designed for cardiac pacing. They are implanted into the heart to help regulate heart rhythms in patients with arrhythmias. These leads are inserted through the venous system and positioned in the atrium and ventricle to deliver electrical impulses that ensure proper heart function.
Clinical Applications
These leads are commonly used in patients with bradycardia or other arrhythmias that require pacing. Cardiologists typically implant these devices in a hospital or surgical setting. They are suitable for adult patients who need long-term pacing support, particularly those with conditions like sick sinus syndrome or heart block.
Indications for Use
The FDA indications suggest these leads are for patients who require cardiac pacing due to arrhythmias. They are specifically used in conditions where the heart's natural pacemaker is not functioning properly.
Practical Considerations
The leads come in various sizes to accommodate different patient anatomies. They are compatible with most pacemaker generators. Proper placement technique is crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is Cordis Encor Pervenous Atrial Ventricular Leads used for?
They are used for cardiac pacing in patients with heart rhythm disorders like bradycardia.
What specialties typically use this device?
Cardiologists typically use these leads in hospital or surgical settings.
What are the FDA-cleared indications?
They are indicated for patients requiring cardiac pacing due to arrhythmias such as 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.