đź“‹ FDA Reference
implant elect lead mod 030-405 using polyu 90 a
Telectronics
Summary: The implant elect lead mod 030-405 by Telectronics is a Class 3 medical device used in cardiac procedures. It is primarily utilized by cardiologists for patients requiring electrical stimulation of the heart.
FDA Clearance Information
Pathway
510K
Number
K852708 ↗
Decision Date
October 1, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implant elect lead mod 030-405 was cleared through the FDA 510(k) pathway on October 1, 1985. Manufactured by Telectronics, it is classified as a Class 3 device under product code DTB.
What It Is
The implant elect lead mod 030-405 is an electrical lead used in cardiac implantable devices. It is designed to deliver electrical impulses to the heart muscle to regulate heartbeats. Made with polyu 90 a, this lead is engineered for durability and compatibility with implantable pulse generators.
Clinical Applications
This device is commonly used in electrophysiology and cardiology settings for patients who require pacemakers or defibrillators. It is typically used in hospital settings, particularly in cardiac catheterization labs or during surgical implantation procedures. The device is suitable for patients with arrhythmias or heart blockages.
Indications for Use
The FDA indications suggest this device is for patients needing electrical stimulation of the heart, such as those with arrhythmias or heart block. It is used to ensure proper heart rhythm and function.
Practical Considerations
The implant elect lead mod 030-405 is available in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemakers and defibrillators. Clinicians should be familiar with lead placement techniques to ensure optimal performance.
Frequently Asked Questions
What is the implant elect lead mod 030-405 used for?
It is used to deliver electrical impulses to the heart in patients requiring cardiac rhythm management.
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 patients needing electrical stimulation of the heart, 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.