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valved tearaway introducer generation ii
Medical Components
Summary: The Valved Tearaway Introducer Generation II is a medical device used primarily in interventional radiology and cardiology for the insertion of catheters and other devices into blood vessels. It is typically used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K124046 ↗
Decision Date
June 3, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Valved Tearaway Introducer Generation II by Medical Components was cleared via the FDA 510(k) pathway on June 3, 2013. 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 facilitate the insertion of catheters and other interventional tools into the vascular system. It features a valve mechanism that helps prevent blood loss during procedures. The tearaway design allows for easy removal of the introducer once the catheter is in place, minimizing trauma to the vessel.
Clinical Applications
This device is commonly used in procedures involving the placement of central venous catheters, pacemaker leads, or other intravascular devices. It is utilized in interventional radiology and cardiology, often in hospital settings where precise vascular access is required. Patients undergoing embolization procedures or those needing long-term intravenous therapy may benefit from its use.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access, such as the placement of embolization coils or other devices. It is suitable for patients needing precise and controlled access to their vascular system.
Practical Considerations
The Valved Tearaway Introducer Generation II is available in various sizes to accommodate different catheter diameters. It is compatible with a range of catheters and should be selected based on the specific procedural requirements. Clinicians should be familiar with the tearaway technique to ensure safe and effective use.
Frequently Asked Questions
What is the Valved Tearaway Introducer Generation II used for?
It is used for the insertion of catheters and other devices into blood vessels, particularly in interventional radiology and cardiology.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for procedures requiring vascular access, such as the placement of embolization coils or other intravascular 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.