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medcomp vascu-sheath introducer set
Medcomp
Summary: The Medcomp Vascu-Sheath Introducer Set is a medical device used for vascular access in interventional procedures. It is typically used by interventional radiologists and cardiologists to facilitate the insertion of catheters or other devices into blood vessels.
FDA Clearance Information
Pathway
510K
Number
K022513 ↗
Decision Date
October 25, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medcomp Vascu-Sheath Introducer Set was cleared through the FDA 510(k) pathway on October 25, 2002. Manufactured by Medcomp, it is classified as a Class II device under product code DYB.
What It Is
The Medcomp Vascu-Sheath Introducer Set is a medical device designed to provide vascular access for the introduction of catheters and other devices into the bloodstream. It consists of a sheath and a dilator, which help in creating a stable and secure entry point into a blood vessel. This device is essential in procedures requiring precise and safe vascular access, minimizing trauma to the vessel wall.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Vascu-Sheath Introducer Set is employed in procedures such as angiography, embolization, and catheter-based interventions. It is particularly useful in settings where rapid and reliable vascular access is critical, such as in emergency departments, catheterization labs, and during minimally invasive surgeries. The device is suitable for a wide range of patient populations, including those requiring diagnostic or therapeutic vascular procedures.
Indications for Use
The FDA indications for the Vascu-Sheath Introducer Set involve its use in facilitating the insertion of devices into the vascular system. It is intended for patients who require vascular access for diagnostic or interventional procedures, such as those undergoing angiographic studies or catheter-based treatments.
Practical Considerations
The Vascu-Sheath Introducer Set is available in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with a range of catheters and devices commonly used in vascular interventions. Clinicians should be familiar with the technique of sheath insertion to minimize complications and ensure optimal outcomes.
Frequently Asked Questions
What is the Medcomp Vascu-Sheath Introducer Set used for?
It is used for providing vascular access to facilitate the insertion of catheters and other devices into the bloodstream during interventional procedures.
What specialties typically use this device?
Interventional radiologists, cardiologists, and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the insertion of devices into the vascular system, particularly for diagnostic or interventional procedures.
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.