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perm endocardial unipolar wedge urethan
Daig
Summary: The perm endocardial unipolar wedge urethan by Daig is a Class III medical device used primarily in cardiac procedures. It is typically utilized by cardiologists and electrophysiologists for specific endocardial applications.
FDA Clearance Information
Pathway
510K
Number
K802553 ↗
Decision Date
January 16, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on January 16, 1981, by Daig. It is classified as a Class III device under product code DTB.
What It Is
The perm endocardial unipolar wedge urethan is a specialized cardiac device designed for endocardial applications. It functions as a unipolar electrode, typically used in procedures requiring precise electrical conduction within the heart. Its design allows for effective integration into cardiac tissue, facilitating accurate monitoring and intervention.
Clinical Applications
This device is commonly used in electrophysiology labs and cardiac catheterization settings. It is employed in procedures like cardiac mapping and ablation, where precise electrical activity monitoring is crucial. Cardiologists and electrophysiologists use it for patients with arrhythmias or other conduction disorders, often in a hospital setting.
Indications for Use
The device is indicated for use in patients requiring endocardial electrical conduction monitoring or intervention. It is particularly useful in managing arrhythmias and other cardiac conduction abnormalities.
Practical Considerations
Clinicians should consider the device's compatibility with existing cardiac monitoring systems. It is important to select the appropriate size and configuration based on the patient's anatomy and the specific procedural requirements. Proper technique in placement is crucial for optimal performance.
Frequently Asked Questions
What is perm endocardial unipolar wedge urethan used for?
It is used for endocardial electrical conduction monitoring and intervention, particularly in cardiac procedures like mapping and ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings, particularly in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring precise endocardial electrical monitoring or intervention, 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.