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radifocus introducer ii kit
Terumo Medical
Summary: The Radifocus Introducer II Kit is a medical device used for vascular access, primarily in interventional radiology and cardiology. It is utilized by healthcare professionals to facilitate the insertion of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K954234 ↗
Decision Date
November 27, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Radifocus Introducer II Kit was cleared through the FDA's 510(k) pathway on November 27, 1995. Manufactured by Terumo Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Radifocus Introducer II Kit is a medical device designed to aid in the insertion of catheters into the vascular system. It typically includes an introducer sheath and dilator, which help guide the catheter through the blood vessel with minimal trauma. This device is essential for procedures requiring vascular access, offering a reliable and efficient means to introduce various interventional tools.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Radifocus Introducer II Kit is employed in procedures such as angiography, embolization, and catheter-based interventions. It is suitable for use in both hospital and outpatient settings, and is often used in patients requiring diagnostic or therapeutic vascular procedures. The device is essential for ensuring safe and effective access to the vascular system, particularly in complex cases.
Indications for Use
The FDA-cleared indications for the Radifocus Introducer II Kit include its use in facilitating vascular access for procedures that require the insertion of catheters or other devices. It is particularly useful in patients undergoing interventional procedures like embolization.
Practical Considerations
The Radifocus Introducer II Kit comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheter sizes and is designed for easy insertion and removal, reducing the risk of vascular trauma. Clinicians should be familiar with the specific technique for using this device to ensure optimal outcomes.
Frequently Asked Questions
What is Radifocus Introducer II Kit used for?
It is used for gaining vascular access to facilitate the insertion of catheters and other interventional devices.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as catheter insertion for diagnostic or therapeutic interventions.
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.