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ancor pervenous active fixation unipolar lead
Cordis
Summary: The Ancor Pervenous Active Fixation Unipolar Lead is a medical device used in cardiac procedures, specifically for pacing. It is utilized by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K864640 ↗
Decision Date
January 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Ancor Pervenous Active Fixation Unipolar Lead was cleared through the FDA 510(k) pathway on January 6, 1987. Manufactured by Cordis, it is classified as a Class III device.
What It Is
The Ancor Pervenous Active Fixation Unipolar Lead is a cardiac pacing lead designed for implantation in the heart. It features an active fixation mechanism, allowing it to be securely attached to the heart tissue. The unipolar design means it uses a single electrode to deliver electrical impulses, which helps regulate heart rhythms in patients with arrhythmias.
Clinical Applications
This device is commonly used in procedures requiring cardiac pacing, such as in patients with bradycardia or heart block. It is typically used in cardiology and electrophysiology departments within hospitals. The patient population includes those with symptomatic arrhythmias who require long-term pacing solutions.
Indications for Use
The Ancor Pervenous Active Fixation Unipolar Lead is indicated for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is designed for use in patients who require a reliable and secure pacing lead.
Practical Considerations
When using this device, clinicians should consider the appropriate lead length and compatibility with the patient's anatomy and existing pacemaker systems. Proper technique in securing the lead is crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is the Ancor Pervenous Active Fixation Unipolar Lead used for?
It is used for cardiac pacing in patients with arrhythmias such as 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?
It is indicated for patients requiring 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.