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valved tearaway introducer generation ii
Medcomp (Medical Components, Inc.)
Summary: The Valved Tearaway Introducer Generation II by Medcomp is a medical device used for vascular access, primarily in interventional radiology and cardiology. It is designed for clinicians to facilitate the introduction of catheters or other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K132498 ↗
Decision Date
November 25, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Valved Tearaway Introducer Generation II was cleared through the FDA 510(k) pathway on November 25, 2013. Manufactured by Medcomp, it is classified as a Class 2 device under product code DYB.
What It Is
The Valved Tearaway Introducer Generation II is a specialized medical device designed to provide vascular access. It features a valve mechanism that helps prevent blood loss and air embolism during catheter insertion. The tearaway design allows for easy removal once the catheter is in place, minimizing trauma to the vessel.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as the placement of central venous catheters or embolization coils. It is frequently utilized in interventional radiology and cardiology settings, particularly in hospitals and specialized clinics. The device is suitable for adult patients requiring precise and secure vascular access.
Indications for Use
The FDA-cleared indications for this device include facilitating the introduction of catheters or other medical devices into the vascular system. It is particularly useful for patients undergoing procedures that require reliable vascular access.
Practical Considerations
The Valved Tearaway Introducer Generation II typically comes in various sizes to accommodate different catheter diameters. It is compatible with a range of catheter types and should be used by trained clinicians familiar with vascular access techniques. Proper technique is essential to minimize complications such as vessel trauma or air embolism.
Frequently Asked Questions
What is the Valved Tearaway Introducer Generation II used for?
It is used to facilitate the introduction of catheters or other medical devices into the vascular system, minimizing blood loss and air embolism.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device for vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters or other devices into the vascular system, particularly in procedures requiring reliable vascular access.
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.