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cordis hi-flex pervenous bipolar lead
Cordis
Summary: The Cordis Hi-Flex Pervenous Bipolar Lead is a medical device used in cardiac pacing. It is primarily utilized by cardiologists for patients requiring pacemaker therapy.
FDA Clearance Information
Pathway
510K
Number
K860846 ↗
Decision Date
June 26, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cordis Hi-Flex Pervenous Bipolar Lead was cleared via the FDA 510k pathway on June 26, 1986. It is manufactured by Cordis and classified as a Class 3 device.
What It Is
The Cordis Hi-Flex Pervenous Bipolar Lead is a specialized lead used in cardiac pacing systems. It functions by transmitting electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The bipolar design allows for more precise sensing and pacing, which is critical for effective cardiac therapy.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other rhythm disorders. Cardiologists and electrophysiologists typically use it in hospital settings, especially in cardiac care units. It is suitable for adult patients who require long-term pacing therapy.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing, such as those with slow heart rates or arrhythmias. It is designed to help maintain a regular heart rhythm.
Practical Considerations
The Cordis Hi-Flex Pervenous Bipolar Lead is available in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemaker systems. Proper technique during insertion is crucial to ensure optimal performance and longevity of the device.
Frequently Asked Questions
What is the Cordis Hi-Flex Pervenous Bipolar Lead used for?
It is used for cardiac pacing in patients with arrhythmias or bradycardia, helping to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device, particularly in hospital cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing, such as those with slow heart rates or irregular heart rhythms.
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.