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implant elect lead mod 30-404 using polyu 90 a
Telectronics
Summary: The Implant Elect Lead Mod 30-404 by Telectronics is an implantable electrical lead used in cardiac procedures. It is primarily utilized by cardiologists and electrophysiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K852710 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Implant Elect Lead Mod 30-404 was cleared through the FDA 510(k) pathway on December 4, 1985. Manufactured by Telectronics, it is classified as a Class III device under product code DTB.
What It Is
The Implant Elect Lead Mod 30-404 is an implantable electrical lead designed for use in cardiac rhythm management. It functions by delivering electrical impulses to the heart to maintain an appropriate heart rate and rhythm. This device is typically used in conjunction with pacemakers or defibrillators to ensure effective cardiac function.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers or implantable cardioverter-defibrillators (ICDs). It is primarily utilized in cardiology and electrophysiology settings, often in hospitals or specialized cardiac care centers. The typical patient population includes individuals with arrhythmias or heart block who require electrical pacing support.
Indications for Use
The FDA indications suggest that this device is intended for patients who need assistance with cardiac rhythm management. It is suitable for those with conditions such as bradycardia or heart block, where maintaining a stable heart rhythm is crucial.
Practical Considerations
When considering this device, clinicians should be aware of the typical sizing and compatibility with various pacemaker or ICD models. Proper technique during implantation is crucial to ensure optimal lead placement and function. Compatibility with other cardiac devices should also be verified.
Frequently Asked Questions
What is the Implant Elect Lead Mod 30-404 used for?
It is used for cardiac rhythm management, typically in conjunction with pacemakers or defibrillators.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac rhythm management, such as those with 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.