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implant elect lead mod 30-403 using polyu 90 a
Telectronics
Summary: The Implant Elect Lead Mod 30-403 is an electrical lead used in cardiac procedures, primarily by cardiologists and electrophysiologists. It is designed for use in implantable cardiac devices.
FDA Clearance Information
Pathway
510K
Number
K852709 ↗
Decision Date
September 17, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on September 17, 1985. Manufactured by Telectronics, it is classified as a Class III device under product code DTB.
What It Is
The Implant Elect Lead Mod 30-403 is a specialized electrical lead used in conjunction with implantable cardiac devices such as pacemakers or defibrillators. Constructed with polyurethane 90A, it is designed to transmit electrical signals between the heart and the device, ensuring proper cardiac rhythm management. This lead is crucial for maintaining cardiac function in patients with arrhythmias.
Clinical Applications
This device is commonly used in cardiac electrophysiology procedures, particularly in the implantation of pacemakers and defibrillators. It is typically utilized in hospital settings by cardiologists and electrophysiologists. The patient population includes those with arrhythmias or heart failure who require rhythm management through implantable devices.
Indications for Use
The FDA indications suggest this device is intended for patients requiring electrical stimulation of the heart, such as those with bradycardia or other rhythm disorders. It is used to ensure the heart maintains a proper rhythm.
Practical Considerations
When considering this device, clinicians should be aware of its compatibility with various implantable cardiac devices. The polyurethane construction offers durability, but care should be taken during implantation to avoid mechanical stress. Proper sizing and placement are crucial for optimal performance.
Frequently Asked Questions
What is Implant Elect Lead Mod 30-403 used for?
It is used to connect implantable cardiac devices like pacemakers to the heart, facilitating electrical signal transmission.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management procedures.
What are the FDA-cleared indications?
It is indicated for patients needing electrical stimulation of the heart, such as those with arrhythmias.
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.