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model 490-01 pacing lead
Intermedics
Summary: The Model 490-01 pacing lead is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K844261 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 490-01 pacing lead was cleared through the FDA 510(k) pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Model 490-01 pacing lead is a medical device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is typically used in conjunction with a pacemaker, which generates the electrical signals. The lead is inserted into the heart via a vein and secured in place to ensure consistent electrical conduction.
Clinical Applications
This pacing lead is commonly used in cardiology for patients with bradycardia or other conditions requiring cardiac pacing. It is typically used in hospital settings, particularly in cardiac catheterization labs or during surgical procedures for pacemaker implantation. The device is suitable for adult and elderly patients who have been diagnosed with heart rhythm disorders.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing due to conditions like bradycardia. It helps maintain a regular heart rate when the heart's natural pacemaker is not functioning properly.
Practical Considerations
The Model 490-01 pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker devices and requires careful insertion technique to ensure proper placement and function. Clinicians should be aware of potential complications such as lead dislodgement or infection.
Frequently Asked Questions
What is the Model 490-01 pacing lead used for?
It is used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for patients needing 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.