📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates percutaneous introduction of catheters and other devices into the vascular system.
- Provides vascular access for diagnostic and interventional procedures requiring catheter or device placement.
Clinical Applications
- Obtaining percutaneous vascular access for angiographic examinations.
- Providing access for catheter-based vascular interventions.
- Introducing compatible catheters or devices during embolization procedures.
- Providing access in interventional radiology, cardiology, and catheterization laboratory procedures.
Practical Considerations
- Available sizes and configurations should be selected according to the access vessel, catheter or device diameter, and procedure requirements.
- The sheath and dilator must be compatible with the intended catheter or interventional device.
- Insertion is generally performed using standard percutaneous vascular access technique and imaging guidance when appropriate.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, dissection, and distal ischemia.
- MRI compatibility and any conditions for use in the MR environment must be confirmed in the current product labeling; the device should not be assumed to be MRI safe.
Procedures that use this device
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.