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model 438-02 cardifix side hook implant pace lead
Intermedics
Summary: The Cardifix Side Hook Implant Pace Lead by Intermedics is a pacing lead used in cardiac procedures to maintain heart rhythm. It is primarily utilized by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K872126 ↗
Decision Date
March 22, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cardifix Side Hook Implant Pace Lead was cleared through the FDA 510(k) pathway on March 22, 1988. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Cardifix Side Hook Implant Pace Lead is a specialized medical device used in cardiac pacing. It is designed to be implanted in the heart to deliver electrical impulses that help maintain a regular heart rhythm. The side hook design aids in secure placement within the cardiac tissue, ensuring effective pacing and reducing the risk of lead dislodgement.
Clinical Applications
This device is commonly used in procedures involving patients with arrhythmias or heart block who require a pacemaker. It is primarily utilized by cardiologists and electrophysiologists in hospital settings, particularly in cardiac catheterization labs or during open-heart surgeries. The device is suitable for adult and geriatric patient populations who have been diagnosed with conditions necessitating cardiac pacing.
Indications for Use
The FDA indications for the Cardifix Side Hook Implant Pace Lead include patients with bradycardia or heart block who require pacing support to maintain adequate heart function. It is intended for use in individuals who need a permanent pacemaker implantation.
Practical Considerations
The Cardifix Side Hook Implant Pace Lead is available in various lengths to accommodate different patient anatomies. It is compatible with standard pacemaker generators. Clinicians should ensure proper placement and secure fixation to optimize device performance and patient outcomes.
Frequently Asked Questions
What is the Cardifix Side Hook Implant Pace Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients with bradycardia or heart block requiring permanent pacemaker implantation.
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.