📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use as an endocardial cardiac pacing electrode in patients who require temporary or permanent cardiac pacing, according to the applicable device labeling.
- For positioning within the heart to provide electrical stimulation for management of cardiac conduction abnormalities.
- Use is limited to the indications, cardiac system compatibility, and implantation instructions specified in the FDA-cleared labeling.
Clinical Applications
- Endocardial cardiac pacing when a unipolar electrode configuration is indicated.
- Placement in the heart by qualified cardiac specialists to provide pacing stimulation.
- Use with compatible cardiac pulse-generator and lead systems identified by the manufacturer.
- Cardiac electrophysiology procedures in which stable endocardial electrode positioning is required for pacing.
Practical Considerations
- The electrode must be matched to a compatible pulse generator, connector, lead system, and pacing configuration.
- Correct sizing and positioning are important for stable contact with the endocardial surface and reliable electrical performance.
- Placement requires appropriate cardiac imaging, electrical testing, and monitoring by clinicians trained in endocardial pacing procedures.
- MRI safety should not be assumed; the specific electrode, implanted system, and manufacturer labeling must be reviewed before MRI.
- Potential complications include arrhythmia, cardiac perforation, bleeding, infection, dislodgement, lead malfunction, and failure to capture; patient-specific contraindications and warnings are described in the labeling.
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.