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model 435-01 cardifix implantable pacing lead
Intermedics
Summary: The Model 435-01 Cardifix Implantable Pacing Lead is a device used in cardiac pacing procedures to deliver electrical impulses to the heart. It is primarily used by cardiologists in settings such as hospitals and specialized cardiac centers.
FDA Clearance Information
Pathway
510K
Number
K854917 ↗
Decision Date
March 11, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 435-01 Cardifix Implantable Pacing Lead was cleared through the FDA 510k pathway on March 11, 1986. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 435-01 Cardifix Implantable Pacing Lead is a medical device designed to be implanted in patients requiring cardiac pacing. It functions by transmitting electrical impulses from a pacemaker to the heart muscle, facilitating proper heart rhythm. This lead is crucial in managing arrhythmias and ensuring effective cardiac output.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically use this device in hospital settings, especially in cardiac care units. It is suitable for adult patients who require long-term pacing therapy.
Indications for Use
The FDA indications suggest this device is intended for patients who need cardiac pacing due to conditions like slow heart rhythms or heart block. It is specifically designed for those who require consistent electrical stimulation to maintain adequate heart function.
Practical Considerations
Clinicians should consider the lead's compatibility with various pacemaker models and ensure proper sizing for individual patients. The implantation technique requires precision to avoid complications and ensure optimal lead placement.
Frequently Asked Questions
What is the Model 435-01 Cardifix Implantable Pacing Lead used for?
It is used for delivering electrical impulses to the heart in patients who require cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to conditions like 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.