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model 438-01 cardifix implantable pacing lead
Intermedics
Summary: The Model 438-01 Cardifix Implantable Pacing Lead is a device used in cardiac pacing to maintain heart rhythm. It is primarily used by cardiologists in patients requiring pacemaker support.
FDA Clearance Information
Pathway
510K
Number
K862052 ↗
Decision Date
July 3, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 438-01 Cardifix Implantable Pacing Lead was cleared via the FDA 510(k) pathway on July 3, 1986. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 438-01 Cardifix is an implantable pacing lead designed to deliver electrical impulses to the heart, ensuring proper heart rhythm in patients with arrhythmias. It is typically used in conjunction with a pacemaker device. The lead is implanted into the heart muscle and connected to the pacemaker, which regulates the heart's electrical activity.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in patients with bradycardia or heart block who require consistent heart rhythm management. It is used in both hospital and outpatient settings, often during surgical implantation of pacemakers. The device is suitable for adult patients who have been diagnosed with conditions that disrupt normal cardiac pacing.
Indications for Use
The FDA indications suggest this device is for patients with conditions like bradycardia, where the heart beats too slowly, or heart block, where electrical signals are delayed or blocked. It helps maintain an adequate heart rate.
Practical Considerations
When considering this device, clinicians should be aware of the typical sizing and compatibility with various pacemaker models. Proper implantation technique is crucial to ensure optimal performance and longevity of the lead. Regular follow-up is recommended to monitor lead function.
Frequently Asked Questions
What is the Model 438-01 Cardifix Implantable Pacing Lead used for?
It is used to maintain heart rhythm in patients with arrhythmias, particularly those with bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of heart rhythm disorders.
What are the FDA-cleared indications?
The device is indicated for patients with conditions like bradycardia or heart block, where maintaining a regular heart rhythm is necessary.
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.