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galt vti low insertion valve tearaway introducer
Galt Medical
Summary: The Galt VTI Low Insertion Valve Tearaway Introducer is a medical device used primarily in interventional radiology and cardiology for vascular access. It is designed for clinicians performing procedures that require the introduction of catheters or other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K140028 ↗
Decision Date
August 21, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Galt VTI Low Insertion Valve Tearaway Introducer was cleared via the FDA 510k pathway on August 21, 2014. Manufactured by Galt Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Galt VTI Low Insertion Valve Tearaway Introducer is a specialized device used to facilitate the insertion of catheters or other medical instruments into the vascular system. It features a low insertion force valve and a tearaway sheath, which allows for smooth entry and removal of devices. This design minimizes trauma to the vessel and enhances procedural efficiency.
Clinical Applications
This device is commonly used in procedures such as embolization, where precise vascular access is critical. It is utilized by interventional radiologists and cardiologists in hospital settings, particularly in catheterization labs. The introducer is suitable for a range of patient populations requiring vascular interventions, including those undergoing treatment for vascular occlusions or aneurysms.
Indications for Use
The FDA-cleared indications for this device include facilitating the insertion of catheters and other devices into the vascular system. It is particularly indicated for procedures that require minimal vessel trauma and efficient device exchange.
Practical Considerations
The Galt VTI introducer is available in various sizes to accommodate different catheter diameters. It is compatible with standard guidewires and catheters used in vascular procedures. Clinicians should be familiar with the tearaway technique to ensure optimal use and minimize complications.
Frequently Asked Questions
What is the Galt VTI Low Insertion Valve Tearaway Introducer used for?
It is used for introducing catheters or other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for facilitating the insertion of catheters and other devices into the vascular system, minimizing vessel trauma.
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.