📋 FDA Reference
Cordis Encor Pewenous Ventricular Bipol
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 ?
510(k)
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.
FDA-Cleared Indications
- Use for ventricular pacing in patients who require electrical stimulation of the ventricle.
- Use as part of a compatible cardiac pacing or monitoring system, according to the device labeling.
Clinical Applications
- Temporary ventricular pacing during cardiac procedures when ventricular stimulation is needed.
- Ventricular pacing or monitoring in a cardiac electrophysiology laboratory.
- Use with compatible cardiac pacing equipment for patients with clinically significant slow heart rates or conduction disturbances, when consistent with the device labeling.
Practical Considerations
- Confirm compatibility with the selected pacemaker, generator, monitoring system, connectors and other accessories before use.
- Placement and testing should be performed by clinicians trained in cardiac pacing and electrophysiology.
- The available FDA record does not provide reliable information on sizes, MRI conditions or service life; consult the original labeling and current institutional policy.
- Assess for patient-specific contraindications and procedural risks, including infection, bleeding, arrhythmia, cardiac perforation and lead displacement.
- Do not assume MRI safety. MRI eligibility depends on the complete implanted or connected system and its labeling.
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.