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implantaid lead introducer 319-10 12
Intermedics
Summary: The Implantaid Lead Introducer 319-10 12 is a medical device used to facilitate the placement of leads during procedures such as pacemaker or defibrillator implantations. It is typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K812502 ↗
Decision Date
October 13, 1981
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Implantaid Lead Introducer 319-10 12 was cleared through the FDA 510k pathway on October 13, 1981. Manufactured by Intermedics, it is classified as a Class 2 device under the product code DYB.
What It Is
The Implantaid Lead Introducer 319-10 12 is a specialized medical device designed to assist in the insertion of leads into the vascular system. It typically consists of a sheath and dilator that guide the lead to its intended location within the body. This device is crucial in procedures requiring precise placement of cardiac leads, ensuring stability and minimizing trauma to the vessel.
Clinical Applications
This device is commonly used in cardiology, particularly in procedures involving the implantation of pacemakers or implantable cardioverter-defibrillators (ICDs). It is utilized in hospital settings, often in cardiac catheterization labs or operating rooms. The device is suitable for adult patients requiring lead placement for cardiac rhythm management.
Indications for Use
The Implantaid Lead Introducer is indicated for use in patients requiring the placement of leads for cardiac devices. It is specifically designed to aid in the precise and safe insertion of these leads into the vascular system, typically for conditions such as arrhythmias or heart failure.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and lead specifications. Compatibility with specific lead types should be verified prior to use. Proper technique during insertion is essential to prevent vascular injury and ensure optimal lead placement.
Frequently Asked Questions
What is the Implantaid Lead Introducer 319-10 12 used for?
It is used to facilitate the insertion of cardiac leads during procedures such as pacemaker or defibrillator implantations.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for the placement of leads in patients requiring cardiac rhythm management devices.
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.