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scoutpro cs lead introducer system
Biotronik
Summary: The scoutpro cs lead introducer system by Biotronik is a medical device used for the introduction of leads into the venous system, primarily in cardiac procedures. It is typically utilized by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K080988 ↗
Decision Date
May 7, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The scoutpro cs lead introducer system received FDA clearance through the 510(k) pathway on May 7, 2008. Manufactured by Biotronik, it is classified as a Class 2 device under product code DQY.
What It Is
The scoutpro cs lead introducer system is designed to facilitate the placement of leads into the venous system, particularly for cardiac pacing and defibrillation procedures. It typically includes a sheath and dilator system that allows for smooth insertion and navigation within the venous anatomy. This device is essential in procedures requiring precise lead placement, such as in the implantation of pacemakers or defibrillators.
Clinical Applications
This device is commonly used in cardiac electrophysiology labs and catheterization labs. It is essential in procedures involving the implantation of cardiac devices like pacemakers and implantable cardioverter-defibrillators (ICDs). Cardiologists and electrophysiologists use it to ensure accurate lead placement in patients requiring cardiac rhythm management, often in settings involving patients with arrhythmias or heart failure.
Indications for Use
The scoutpro cs lead introducer system is indicated for use in patients requiring the placement of leads for cardiac rhythm management devices. This includes patients with conditions such as arrhythmias or heart failure who need pacemakers or ICDs.
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 procedures. Clinicians should be familiar with the technique of lead introduction and the specific compatibility requirements of the device.
Frequently Asked Questions
What is the scoutpro cs lead introducer system used for?
It is used for the introduction of leads into the venous system during cardiac procedures, such as the implantation of pacemakers and ICDs.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac electrophysiology and catheterization labs.
What are the FDA-cleared indications?
The device is indicated for the placement of leads in patients requiring cardiac rhythm management devices, such as pacemakers and ICDs.
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.