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subclavian lead introducer sys
Xanmed
Summary: The subclavian lead introducer system by Xanmed is a medical device used to facilitate the insertion of leads into the subclavian vein. It is commonly used by cardiologists and electrophysiologists during procedures such as pacemaker or defibrillator implantation.
FDA Clearance Information
Pathway
510K
Number
K843642 ↗
Decision Date
October 23, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 23, 1984, by Xanmed. It is classified as a Class 2 medical device under product code DYB.
What It Is
The subclavian lead introducer system is a specialized medical tool designed to assist in the placement of electrical leads into the subclavian vein. It typically consists of a sheath and dilator that guide the lead into the vein with precision. This system is crucial in procedures requiring the implantation of cardiac devices, ensuring safe and effective lead placement.
Clinical Applications
This device is primarily used in cardiology and electrophysiology settings, particularly during the implantation of pacemakers and implantable cardioverter-defibrillators (ICDs). It is used in hospital settings, often in catheterization labs or operating rooms. The patient population includes those requiring cardiac rhythm management, such as individuals with arrhythmias or heart failure.
Indications for Use
The subclavian lead introducer system is indicated for use in patients who require the placement of leads into the subclavian vein, typically for cardiac device implantation. It is suitable for patients undergoing procedures like pacemaker or ICD placement.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and lead types. It is compatible with standard lead systems used in cardiac device implantation. Clinicians should be familiar with the technique of subclavian vein access and lead placement to ensure optimal outcomes.
Frequently Asked Questions
What is the subclavian lead introducer system used for?
It is used to facilitate the insertion of electrical leads into the subclavian vein during cardiac device implantation procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during procedures involving cardiac rhythm management.
What are the FDA-cleared indications?
The device is indicated for use in the placement of leads into the subclavian vein, commonly for pacemaker or ICD 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.