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model 493-01 pacing lead
Intermedics
Summary: The model 493-01 pacing lead by Intermedics 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
K844263 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 493-01 pacing lead by Intermedics was cleared through the FDA 510(k) pathway on March 28, 1985. It is classified as a Class III device under product code DTB.
What It Is
The model 493-01 pacing lead is a medical device designed to provide electrical stimulation to the heart, ensuring proper heart rhythm in patients with arrhythmias. It is implanted into the heart and connected to a pacemaker, which sends electrical impulses through the lead to regulate the heartbeat. This device is crucial for patients with bradycardia or other heart rhythm disorders.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology and cardiac surgery settings. It is utilized in procedures for patients with symptomatic bradycardia or heart block, where maintaining an adequate heart rate is essential. The device is suitable for adult and geriatric patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest that this device is intended for patients who need assistance in maintaining a regular heart rhythm. This includes individuals with conditions like bradycardia or heart block, where the heart beats too slowly or irregularly.
Practical Considerations
The model 493-01 pacing lead is typically compatible with a range of pacemakers. Clinicians should consider the patient's anatomy and the lead's length and flexibility during implantation. Proper technique is crucial to ensure lead stability and function.
Frequently Asked Questions
What is the model 493-01 pacing lead used for?
It is used to deliver electrical impulses to the heart to maintain a proper heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing assistance in maintaining a regular heart rhythm, such as those with 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.