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ivt introducer sheath
Intensive Technology
Summary: The IVT Introducer Sheath by Intensive Technology is a medical device used to facilitate the introduction of catheters and other instruments into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K903463 ↗
Decision Date
January 3, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The IVT Introducer Sheath was cleared through the FDA 510(k) pathway on January 3, 1991. It is manufactured by Intensive Technology and classified as a Class 2 device under product code DYB.
What It Is
The IVT Introducer Sheath is a tubular device designed to provide a conduit for the insertion of catheters and other instruments into the vascular system. It typically consists of a flexible tube with a hemostatic valve to minimize blood loss during procedures. This device is essential in procedures requiring vascular access, allowing for smooth and safe insertion of various interventional tools.
Clinical Applications
Commonly used in interventional radiology and cardiology, the IVT Introducer Sheath facilitates procedures such as angiography, embolization, and catheter-based interventions. It is used in hospital settings, particularly in catheterization labs and interventional suites, and is suitable for adult and pediatric patients requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The FDA indications for the IVT Introducer Sheath include its use in procedures requiring vascular access. It is intended for patients needing catheter-based interventions, such as those undergoing angiographic studies or embolization procedures.
Practical Considerations
The IVT Introducer Sheath is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with standard vascular access equipment and requires careful insertion technique to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the IVT Introducer Sheath used for?
The IVT Introducer Sheath is used to facilitate the introduction of catheters and other instruments into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the IVT Introducer Sheath in procedures requiring vascular access.
What are the FDA-cleared indications?
The FDA-cleared indications include use in procedures requiring vascular access, such as angiography and embolization.
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.