📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use as an implantable cardiac electrical lead in a cardiac pacing or rhythm-management system.
- For patients requiring electrical stimulation of the heart as part of an implanted cardiac device system.
Clinical Applications
- Implantation as part of a pacemaker system for patients requiring cardiac pacing.
- Use in cardiac rhythm-management procedures involving an implanted pulse generator.
- Placement by cardiology or electrophysiology teams when an implantable cardiac lead is clinically indicated.
Practical Considerations
- Confirm that the lead is compatible with the intended pulse generator and connector system before implantation.
- Lead placement, testing and fixation require appropriate cardiac imaging, electrical measurements and sterile technique.
- The available record does not provide lead dimensions, fixation style, conductor configuration or current MRI-conditional labeling; consult the original device labeling before use.
- Evaluate for patient-specific risks such as infection, venous access limitations, lead dislodgement, perforation and thrombosis.
- Do not assume MRI safety from the lead name alone. MRI eligibility depends on the complete implanted system and its labeling.
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.