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implant endocardial dish tip elect lds
Telectronics
Summary: The Implant Endocardial Dish Tip Elect LDS by Telectronics is a Class III medical device used in cardiac procedures. It is typically utilized by cardiologists for specific heart-related interventions.
FDA Clearance Information
Pathway
510K
Number
K802413 ↗
Decision Date
January 2, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on January 2, 1981. Manufactured by Telectronics, it is classified as a Class III device under product code DTB.
What It Is
The Implant Endocardial Dish Tip Elect LDS is a specialized cardiac device designed for endocardial applications. It features a dish-shaped tip that facilitates electrical stimulation or sensing within the heart. This device is integral in procedures requiring precise cardiac monitoring or intervention, providing reliable performance in complex cardiac environments.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is suitable for patients requiring detailed cardiac electrical mapping or pacing. The device is often employed in procedures involving arrhythmia management, where precise electrical stimulation is critical.
Indications for Use
The device is indicated for use in patients who require endocardial electrical stimulation or sensing. It is particularly beneficial for those with specific cardiac conditions that necessitate precise electrical intervention.
Practical Considerations
Clinicians should be aware of the device's compatibility with existing cardiac equipment. Proper sizing and placement technique are crucial for optimal performance. Familiarity with the device's electrical properties can enhance procedural outcomes.
Frequently Asked Questions
What is Implant Endocardial Dish Tip Elect LDS used for?
It is used for endocardial electrical stimulation or sensing in cardiac procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac procedures.
What are the FDA-cleared indications?
It is indicated for patients needing endocardial electrical stimulation or sensing, particularly in cardiac conditions requiring precise intervention.
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.