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encor unipolar vs-1 leads
Cordis Leads
Summary: The Encor Unipolar VS-1 Leads are medical devices used in cardiac procedures to provide electrical stimulation to the heart. They are primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K883070 ↗
Decision Date
December 5, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Encor Unipolar VS-1 Leads were cleared by the FDA via the 510k pathway on December 5, 1988. Manufactured by Cordis Leads, this device is classified as Class 3 under product code DTB.
What It Is
The Encor Unipolar VS-1 Leads are specialized cardiac leads designed to deliver electrical impulses to the heart muscle. These leads are used in conjunction with pacemakers or defibrillators to manage arrhythmias. Their unipolar design allows for a single electrode to be used, which can be advantageous in certain clinical scenarios.
Clinical Applications
These leads are commonly used in procedures involving the implantation of pacemakers or implantable cardioverter-defibrillators (ICDs). They are typically utilized in cardiology and electrophysiology settings, particularly in hospitals and specialized cardiac centers. Patients with conditions such as bradycardia or heart block may benefit from these leads.
Indications for Use
The FDA indications for the Encor Unipolar VS-1 Leads include use in patients requiring cardiac pacing or defibrillation. This typically involves patients with arrhythmias or heart rhythm disorders.
Practical Considerations
The Encor Unipolar VS-1 Leads are compatible with most modern pacemakers and ICDs. Clinicians should be aware of the specific sizing and compatibility requirements when selecting these leads for implantation. Proper technique during implantation is crucial to ensure optimal performance and patient safety.
Frequently Asked Questions
What is Encor Unipolar VS-1 Leads used for?
These leads are used to deliver electrical impulses to the heart in patients requiring pacing or defibrillation.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use these leads in cardiac procedures.
What are the FDA-cleared indications?
The leads are indicated for use in patients needing cardiac pacing or defibrillation, such as those with 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.