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encor bipolar act fixa lead w por sur ele 329-201
Cordis Leads
Summary: The Encor Bipolar Act Fixa Lead is a medical device used in cardiac procedures, specifically for pacing. It is utilized by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K874366 ↗
Decision Date
June 16, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Encor Bipolar Act Fixa Lead was cleared through the FDA 510k pathway on June 16, 1988. Manufactured by Cordis Leads, it is classified as a Class III device.
What It Is
The Encor Bipolar Act Fixa Lead is a specialized cardiac lead used in pacing systems. It features bipolar electrodes that allow for precise electrical conduction to the heart muscle. The device is designed to be implanted in patients requiring cardiac rhythm management, ensuring effective pacing and synchronization of the heart's electrical activity.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers or defibrillators. It is primarily used by cardiologists and electrophysiologists in hospitals and specialized cardiac centers. The lead is suitable for patients with arrhythmias or heart blockages that necessitate consistent pacing to maintain adequate cardiac function.
Indications for Use
The FDA indications suggest that this lead is intended for patients who require cardiac pacing due to conditions like bradycardia or heart block. It is designed to ensure reliable pacing and conduction in patients with compromised heart rhythm.
Practical Considerations
The Encor Bipolar Act Fixa Lead typically comes in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemaker systems and requires careful implantation technique to ensure optimal positioning and function.
Frequently Asked Questions
What is Encor Bipolar Act Fixa Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like 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.