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model 431-01 biopore implantable pacing lead
Intermedics
Summary: The Model 431-01 Biopore Implantable Pacing Lead is a medical device used for cardiac pacing. It is primarily used by cardiologists for patients requiring pacing therapy.
FDA Clearance Information
Pathway
510K
Number
K854918 ↗
Decision Date
March 11, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 431-01 Biopore Implantable Pacing Lead was cleared through the FDA 510(k) pathway on March 11, 1986. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Model 431-01 Biopore Implantable Pacing Lead is a device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is implanted into the heart tissue and connected to a pacemaker. The lead features a biopore design that enhances tissue integration and stability within the heart.
Clinical Applications
This pacing lead is commonly used in cardiac procedures where patients require pacing support, such as in cases of bradycardia or heart block. It is typically used in hospital settings by cardiologists and electrophysiologists. The device is suitable for adult patients who need long-term pacing therapy.
Indications for Use
The device is indicated for patients with conditions that necessitate cardiac pacing, such as slow heart rhythms or heart block. It helps maintain a regular heart rate by delivering electrical impulses to the heart.
Practical Considerations
The pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with a range of pacemakers. Implantation requires precise placement and fixation within the heart, typically performed in a catheterization lab.
Frequently Asked Questions
What is the Model 431-01 Biopore Implantable Pacing Lead used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like slow heart rhythms 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.