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model 435-04 cardifix side hook implant pace lead
Intermedics
Summary: The Model 435-04 Cardifix Side Hook Implant Pace Lead by Intermedics is a cardiac pacing lead used in pacemaker implantation. It is primarily used by cardiologists and electrophysiologists to ensure proper cardiac pacing in patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K875178 ↗
Decision Date
May 25, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 435-04 Cardifix Side Hook Implant Pace Lead was cleared through the FDA 510(k) pathway on May 25, 1988. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 435-04 Cardifix Side Hook Implant Pace Lead is a medical device used in cardiac pacing systems. It functions as an electrical conduit between the pacemaker and the heart, delivering electrical impulses to regulate heartbeats. The side hook design aids in secure attachment to the heart tissue, ensuring reliable performance.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, typically performed by cardiologists or electrophysiologists. It is used in hospital settings, particularly in cardiac catheterization labs or operating rooms. The device is suitable for patients with bradycardia or other arrhythmias requiring consistent cardiac pacing.
Indications for Use
The FDA indications suggest this device is intended for patients requiring cardiac pacing due to arrhythmias. It is specifically designed for those who need a reliable connection between the pacemaker and the heart.
Practical Considerations
Clinicians should consider the lead's compatibility with various pacemaker models and the specific anatomical considerations of the patient. Proper technique in securing the side hook is essential for optimal performance and longevity of the pacing system.
Frequently Asked Questions
What is the Model 435-04 Cardifix Side Hook Implant Pace Lead used for?
It is used to connect a pacemaker to the heart, delivering electrical impulses to regulate heartbeats in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias, ensuring a reliable connection between the pacemaker and the heart.
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.