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model 492-01 pacing lead
Intermedics
Summary: The model 492-01 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
K844266 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 492-01 pacing lead by Intermedics was cleared through the FDA 510k pathway on March 28, 1985. It is a Class III device under product code DTB.
What It Is
The model 492-01 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. The lead is inserted into the heart via a vein and positioned to ensure optimal pacing. This device is crucial for patients with arrhythmias or heart block who require consistent cardiac pacing.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in the management of patients with bradycardia or heart block. It is typically implanted in a hospital setting, often in a cardiac catheterization lab or operating room. The device is suitable for adult and pediatric patients who require temporary or permanent pacing support.
Indications for Use
The model 492-01 pacing lead is indicated for patients who need electrical pacing of the heart, such as those with slow heart rhythms or heart block. It helps maintain an adequate heart rate in these patients.
Practical Considerations
The pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Proper placement and secure fixation are crucial for optimal performance and longevity of the device.
Frequently Asked Questions
What is the model 492-01 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?
Cardiology and cardiac surgery specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for patients needing electrical pacing of the heart, 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.