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implantable electrode adaptor assemble
Telectronics
Summary: The implantable electrode adaptor assemble by Telectronics is a device used to facilitate the connection of electrodes in implantable systems. It is primarily used by cardiologists and electrophysiologists in cardiac procedures.
FDA Clearance Information
Pathway
510K
Number
K851461 ↗
Decision Date
July 11, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode adaptor assemble was cleared through the FDA 510k pathway on July 11, 1985. It is manufactured by Telectronics and classified as a Class III device.
What It Is
This device is an adaptor used in implantable cardiac systems to connect electrodes to the main device, such as a pacemaker or defibrillator. It ensures stable and reliable electrical connections, which are crucial for the proper functioning of the implantable system. The adaptor is designed to be biocompatible and durable, suitable for long-term implantation.
Clinical Applications
The implantable electrode adaptor assemble is commonly used in cardiac procedures involving pacemakers or defibrillators. It is utilized in settings such as hospitals and specialized cardiac centers. Cardiologists and electrophysiologists use this device for patients requiring cardiac rhythm management, particularly those with arrhythmias or heart failure.
Indications for Use
This device is indicated for patients who need an implantable cardiac device, such as a pacemaker or defibrillator, and require stable electrode connections. It is suitable for individuals with conditions like arrhythmias or heart block.
Practical Considerations
The adaptor is typically compatible with a range of electrode sizes and types used in cardiac devices. Clinicians should ensure compatibility with the specific implantable device being used. Proper technique during implantation is crucial to ensure secure connections and device functionality.
Frequently Asked Questions
What is the implantable electrode adaptor assemble used for?
It is used to connect electrodes to implantable cardiac devices like pacemakers and defibrillators.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
It is indicated for use in patients requiring implantable cardiac devices for conditions such as arrhythmias 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.