đź“‹ FDA Reference
implantable electrode lead model 030-400
Telectronics
Summary: The implantable electrode lead model 030-400 by Telectronics is used in cardiac pacing systems. It is primarily utilized by cardiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K852972 ↗
Decision Date
September 16, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode lead model 030-400 by Telectronics was cleared through the FDA 510k process on September 16, 1985. It is classified as a Class 3 device under product code DTB.
What It Is
The implantable electrode lead model 030-400 is a component of cardiac pacemaker systems. It functions by delivering electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. The lead is designed to be implanted within the heart or attached to the heart's surface, facilitating effective cardiac pacing.
Clinical Applications
This device is commonly used in cardiology, particularly in procedures involving the implantation of pacemakers. It is suitable for patients with arrhythmias or other conditions that require cardiac rhythm management. The lead is typically used in hospital settings, including operating rooms and cardiac catheterization labs.
Indications for Use
The implantable electrode lead is indicated for patients who need cardiac pacing due to arrhythmias or heart block. It is used in conjunction with a pacemaker to maintain an adequate heart rate.
Practical Considerations
When considering this device, clinicians should be aware of the lead's compatibility with various pacemaker models. Proper sizing and placement technique are crucial for optimal performance and patient outcomes.
Frequently Asked Questions
What is implantable electrode lead model 030-400 used for?
It is used in cardiac pacing systems to manage heart rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to 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.