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intermedics model 431-11 implant endocard pac lead
Intermedics
Summary: The Intermedics Model 431-11 Implant Endocard Pac Lead is a cardiac pacing lead used in pacemaker systems to manage arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K903948 ↗
Decision Date
April 22, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Model 431-11 Implant Endocard Pac Lead was cleared via the FDA 510(k) pathway on April 22, 1991. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Intermedics Model 431-11 is an implantable endocardial pacing lead designed to deliver electrical impulses from a pacemaker to the heart. It helps regulate heart rhythms in patients with arrhythmias. The lead is inserted through a vein and positioned in the heart, where it senses cardiac activity and delivers pacing as needed.
Clinical Applications
This pacing lead is commonly used in procedures to address bradycardia or other arrhythmias requiring pacemaker intervention. It is typically utilized in cardiology departments within hospitals, especially in patients who require long-term cardiac rhythm management. The device is suitable for adult patients with conditions like sick sinus syndrome or heart block.
Indications for Use
The device is indicated for patients who need cardiac pacing due to conditions like slow heart rate (bradycardia) or heart block. It is used in conjunction with a pacemaker to ensure proper heart rhythm.
Practical Considerations
The lead is compatible with various pacemaker models and comes in different lengths to accommodate patient anatomy. Proper placement and secure fixation are crucial for optimal performance, and clinicians should be trained in lead implantation techniques.
Frequently Asked Questions
What is Intermedics Model 431-11 Implant Endocard Pac Lead used for?
It is used for cardiac pacing in patients with arrhythmias, such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for cardiac pacing in patients with conditions like bradycardia 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.