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unipolar endocardial laser drilled elec
Telectronics
Summary: The unipolar endocardial laser drilled electrode by Telectronics is a cardiac device used in electrophysiology for cardiac pacing. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K802968 ↗
Decision Date
December 22, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The unipolar endocardial laser drilled electrode was cleared via the FDA 510k pathway on December 22, 1980. It is manufactured by Telectronics and classified as a Class 3 device.
What It Is
This device is a specialized electrode used in cardiac pacing procedures. It features laser-drilled holes to enhance electrical conductivity and ensure stable pacing. The unipolar design allows for specific targeting of cardiac tissue, making it effective in managing arrhythmias.
Clinical Applications
The device is commonly used in electrophysiology labs during procedures to manage arrhythmias such as bradycardia. It is particularly useful in patients requiring precise pacing interventions. Cardiologists and electrophysiologists in hospital settings typically utilize this device for its reliability and precision.
Indications for Use
The device is indicated for patients with cardiac arrhythmias who require pacing support. It is suitable for individuals with conditions like bradycardia or heart block where stable and reliable pacing is critical.
Practical Considerations
The electrode is typically available in various lengths to accommodate different patient anatomies. It is compatible with standard pacing systems. Clinicians should be familiar with laser-drilled electrode handling techniques to ensure optimal placement and function.
Frequently Asked Questions
What is the unipolar endocardial laser drilled electrode used for?
It is used for cardiac pacing in patients with arrhythmias, providing stable and reliable electrical conduction.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients with cardiac arrhythmias requiring pacing support, such as those with 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.