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perm endocardial unipolar tined wedge
Daig
Summary: The perm endocardial unipolar tined wedge is a medical device used primarily in cardiac procedures. It is typically utilized by cardiologists and electrophysiologists for specific heart-related interventions.
FDA Clearance Information
Pathway
510K
Number
K802552 ↗
Decision Date
January 16, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The perm endocardial unipolar tined wedge, manufactured by Daig, was cleared by the FDA via the 510k pathway on January 16, 1981. It is classified as a Class III device under product code DTB.
What It Is
This device is a specialized cardiac tool designed for endocardial applications. Its unipolar configuration and tined design allow for secure placement within the heart tissue. It is primarily used in procedures that require precise electrical conduction or pacing within the heart, providing reliable performance in complex cardiac interventions.
Clinical Applications
Commonly used in electrophysiology labs, this device is integral in procedures such as cardiac pacing or mapping. It is particularly relevant in settings where precise cardiac conduction is necessary, such as in the treatment of arrhythmias. The device is used by cardiologists and electrophysiologists in both hospital and specialized cardiac care settings.
Indications for Use
The FDA indications suggest this device is suitable for patients requiring endocardial interventions, particularly those with cardiac conduction abnormalities. It is used in procedures that necessitate stable and reliable cardiac pacing.
Practical Considerations
Clinicians should consider the specific sizing and compatibility with existing cardiac systems when using this device. Proper technique is essential for secure placement, and familiarity with endocardial procedures is recommended for optimal outcomes.
Frequently Asked Questions
What is the perm endocardial unipolar tined wedge used for?
It is used in cardiac procedures to ensure stable electrical conduction or pacing within the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring endocardial interventions, particularly for cardiac pacing and conduction management.
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.