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implantable endocardial porous tip elec
Telectronics
Summary: The implantable endocardial porous tip electrode by Telectronics is a device used in cardiology for cardiac pacing. It is primarily utilized by cardiologists for patients requiring long-term cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K801792 ↗
Decision Date
October 23, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA's 510(k) pathway on October 23, 1980. Manufactured by Telectronics, it is classified as a Class III device under product code DTB.
What It Is
The implantable endocardial porous tip electrode is a cardiac pacing device designed to be implanted within the heart. It features a porous tip that facilitates stable electrical contact with cardiac tissue, ensuring effective pacing. This device is crucial for patients with arrhythmias who require consistent heart rhythm management.
Clinical Applications
Commonly used in cardiology, this device is implanted in patients with bradycardia or other rhythm disorders requiring pacemaker support. It is typically utilized in hospital settings during cardiac surgery or interventional procedures. The primary patient population includes those with symptomatic heart block or sick sinus syndrome.
Indications for Use
The FDA indications suggest this device is for patients needing cardiac pacing due to arrhythmias. It is specifically indicated for those with conditions like heart block or bradycardia, where maintaining a regular heart rhythm is critical.
Practical Considerations
When considering this device, clinicians should be aware of the typical sizing options to ensure proper fit within the patient's heart. Compatibility with existing pacemaker systems and careful implantation technique are crucial for optimal performance.
Frequently Asked Questions
What is the implantable endocardial porous tip electrode used for?
It is used for cardiac pacing in patients with arrhythmias, particularly those with bradycardia or heart block.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device in both surgical and interventional cardiology settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like heart block or bradycardia.
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.