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flip introducer access kit
Vascular Solutions
Summary: The Flip Introducer Access Kit is a medical device used to facilitate vascular access, primarily in interventional radiology and cardiology. It is typically utilized by specialists during procedures requiring embolization coils.
FDA Clearance Information
Pathway
510K
Number
K132789 ↗
Decision Date
April 17, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Flip Introducer Access Kit was cleared through the FDA 510(k) pathway on April 17, 2014. Manufactured by Vascular Solutions, it is classified as a Class 2 device under product code DYB.
What It Is
The Flip Introducer Access Kit is designed to aid in the introduction of catheters and other devices into the vascular system. It typically includes a sheath and dilator, allowing for smooth and controlled access to blood vessels. This device is particularly useful in procedures where precision and stability are critical, such as the placement of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures involving vascular access, such as embolization. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites. The device is often used in adult patients requiring treatment for conditions like aneurysms or arteriovenous malformations.
Indications for Use
The FDA indications for the Flip Introducer Access Kit involve facilitating access to the vascular system for the placement of embolization coils. It is used in patients who require precise vascular interventions to treat conditions like aneurysms.
Practical Considerations
The Flip Introducer Access Kit is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and catheters. Clinicians should be familiar with the technique of vascular access and ensure proper sizing to minimize complications.
Frequently Asked Questions
What is Flip Introducer Access Kit used for?
It is used to facilitate vascular access for the placement of embolization coils 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?
The device is indicated for facilitating vascular access for the placement of embolization coils in patients requiring such 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.