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cordis encor pewenous ventricular bipol
Cordis
Summary: The Cordis Encor Pewenous Ventricular Bipol is a Class 3 medical device used primarily in cardiac procedures. It is utilized by cardiologists and electrophysiologists for ventricular pacing and monitoring.
FDA Clearance Information
Pathway
510K
Number
K811539 ↗
Decision Date
July 1, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cordis Encor Pewenous Ventricular Bipol was cleared through the FDA 510k pathway on July 1, 1981. Manufactured by Cordis, it is classified as a Class 3 device under product code DTB.
What It Is
The Cordis Encor Pewenous Ventricular Bipol is a specialized cardiac device designed for ventricular pacing. It operates by delivering electrical impulses to the heart muscle to maintain an adequate heart rate, especially in patients with arrhythmias. This device is typically used in conjunction with other cardiac monitoring and pacing systems.
Clinical Applications
This device is commonly used in cardiac electrophysiology labs and during cardiac surgeries. It is essential for procedures involving ventricular pacing, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists in hospital settings are the primary users, often dealing with adult and geriatric populations.
Indications for Use
The device is indicated for patients requiring ventricular pacing due to conditions like bradycardia or heart block. It helps maintain a regular heart rhythm in patients with compromised cardiac function.
Practical Considerations
When using the Cordis Encor Pewenous Ventricular Bipol, clinicians should consider the compatibility with existing cardiac pacing systems. Proper sizing and placement are crucial for effective pacing and patient safety. Training in electrophysiology is recommended for optimal use.
Frequently Asked Questions
What is Cordis Encor Pewenous Ventricular Bipol used for?
It is used for ventricular pacing in patients with arrhythmias such as bradycardia or heart block.
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 ventricular pacing in patients with 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.