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model 438-03 cardifix side hook implant pace lead
Intermedics
Summary: The Model 438-03 Cardifix Side Hook Implant Pace Lead is a cardiac pacing lead used in patients requiring pacemaker therapy. It is utilized by cardiologists and electrophysiologists to ensure effective cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K875100 ↗
Decision Date
May 24, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 438-03 Cardifix Side Hook Implant Pace Lead was cleared through the FDA 510(k) pathway on May 24, 1988. Manufactured by Intermedics, it is classified as a Class III medical device.
What It Is
The Model 438-03 Cardifix Side Hook Implant Pace Lead is a specialized lead used in cardiac pacing systems. It features a side hook design to secure the lead in place within the heart's chambers. This device is crucial for ensuring consistent electrical stimulation to maintain adequate heart rhythm in patients with arrhythmias or heart block.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other conduction disorders. It is typically used in hospital settings by cardiologists and electrophysiologists. The patient population includes those with symptomatic heart rhythm disorders requiring long-term pacing support.
Indications for Use
The FDA indications suggest this device is intended for patients who require cardiac pacing due to conditions like bradycardia or heart block. It is suitable for individuals who need consistent heart rhythm management.
Practical Considerations
The Model 438-03 lead is compatible with a variety of pacemaker generators. Clinicians should be aware of the lead's sizing and ensure proper placement technique to avoid dislodgement. Regular follow-up is essential to monitor lead function and patient response.
Frequently Asked Questions
What is the Model 438-03 Cardifix Side Hook Implant Pace Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to 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.