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model 431-02 biopore implantable pacing lead
Intermedics
Summary: The model 431-02 biopore implantable pacing lead is a cardiac pacing lead used in patients requiring pacemaker therapy. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K862257 ↗
Decision Date
July 10, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 431-02 biopore implantable pacing lead by Intermedics was cleared through the FDA 510(k) pathway on July 10, 1986. It is classified as a Class III device under product code DTB.
What It Is
The model 431-02 biopore implantable pacing lead is a medical device designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper cardiac rhythm. It features a biopore design to enhance tissue ingrowth and stability within the heart. This lead is crucial for patients with arrhythmias who require consistent heart pacing to maintain adequate cardiac output.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. It is typically utilized by cardiologists and electrophysiologists in hospital settings, including cardiac catheterization labs and operating rooms. The device is suitable for a wide range of patients, including those with chronic heart rhythm disorders.
Indications for Use
The FDA indications suggest this device is for patients who require cardiac pacing due to conditions like bradycardia or atrioventricular block. It is intended to help maintain a regular heart rhythm in patients with these conditions.
Practical Considerations
The model 431-02 lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker devices and requires careful handling during implantation to ensure proper positioning and function. Clinicians should be familiar with the specific implantation techniques to optimize outcomes.
Frequently Asked Questions
What is the model 431-02 biopore implantable pacing lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart muscle in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device, particularly in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients who require cardiac pacing due to conditions like bradycardia or atrioventricular 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.