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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 ?
510(k)
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.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation of the heart.
- Use with an implantable pacemaker system to deliver pacing impulses to the heart muscle.
- Pacing for clinically significant bradycardia or cardiac conduction disorders, including heart block, when indicated for pacemaker therapy.
Clinical Applications
- Implantation as part of a permanent pacemaker system.
- Delivery of electrical impulses from a pacemaker generator to the heart.
- Treatment of patients requiring long-term pacing for slow heart rhythms.
- Treatment of selected patients with heart block or other clinically significant conduction disorders.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and the complete pacing system.
- Lead size, length, fixation method, and intended chamber placement should be confirmed from the original device labeling before implantation.
- Implantation requires fluoroscopic or other appropriate imaging guidance and testing of lead position and electrical performance.
- MRI safety should not be assumed. This older lead should be treated as MR-conditional or MR-unsafe only according to the original labeling and the requirements of the complete implanted system.
- Potential complications include bleeding, infection, lead dislodgement, venous thrombosis, perforation, abnormal heart rhythms, and lead malfunction.
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.