đź“‹ FDA Reference
model 492-02 endocardial pacing lead
Intermedics
Summary: The model 492-02 endocardial pacing lead by Intermedics is a device used for cardiac pacing. It is primarily used by cardiologists to manage heart rhythm disorders in patients requiring pacemaker therapy.
FDA Clearance Information
Pathway
510K
Number
K860548 ↗
Decision Date
June 13, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 492-02 endocardial pacing lead was cleared through the FDA 510(k) pathway on June 13, 1986. Manufactured by Intermedics, this device is classified as a Class III medical device.
What It Is
The model 492-02 endocardial pacing lead is a medical device designed to deliver electrical impulses to the heart muscle to regulate heartbeats. 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 positioned to ensure optimal contact with the heart tissue for effective pacing.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology, to treat patients with bradycardia or other rhythm disorders. It is often used in hospital settings, including cardiac catheterization labs and operating rooms, for patients who require long-term pacing support. The device is suitable for adult patients who have conditions that necessitate the use of a pacemaker.
Indications for Use
The model 492-02 endocardial pacing lead is indicated for patients who need assistance in maintaining a regular heart rhythm due to conditions like bradycardia. It is used in patients who have been diagnosed with heart rhythm disorders that require electrical pacing intervention.
Practical Considerations
Clinicians should consider the lead's compatibility with different pacemaker models. Proper sizing and positioning are crucial for effective pacing and minimizing complications. Familiarity with insertion techniques and potential anatomical variations is important for successful implantation.
Frequently Asked Questions
What is the model 492-02 endocardial pacing lead used for?
It is used to deliver electrical impulses to the heart to regulate heartbeats in patients with rhythm disorders.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing assistance in maintaining a regular heart rhythm 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.