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model 435-03 side hook implantable pacing lead
Intermedics
Summary: The model 435-03 side hook implantable pacing lead is a cardiac device used for pacing in patients with arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K870948 ↗
Decision Date
April 10, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 435-03 side hook implantable pacing lead was cleared by the FDA through the 510(k) process on April 10, 1987. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The model 435-03 side hook implantable pacing lead is a medical device designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. It features a side hook mechanism for stable attachment to the heart tissue. This device is typically used in conjunction with a pacemaker to treat patients with bradycardia or other arrhythmias.
Clinical Applications
This pacing lead is commonly used in cardiac electrophysiology procedures to manage arrhythmias. It is typically implanted in patients who require long-term cardiac pacing, such as those with heart block or sick sinus syndrome. The device is used in hospital settings, particularly in cardiology departments, and is handled by electrophysiologists and cardiothoracic surgeons.
Indications for Use
The FDA indications suggest this device is for patients who require cardiac pacing due to arrhythmias like bradycardia. It is suitable for individuals who need consistent heart rate management.
Practical Considerations
The model 435-03 is compatible with a range of pacemakers and is available in various lengths to accommodate different patient anatomies. Proper placement and secure attachment are crucial for optimal performance, and clinicians should be trained in implantation techniques.
Frequently Asked Questions
What is the model 435-03 side hook implantable pacing lead used for?
It is used to deliver electrical impulses to the heart to maintain a regular heart rate in patients with arrhythmias.
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 patients requiring cardiac pacing due to conditions like bradycardia.
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.