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the wand microaccess safety introducer models 90001 90002 90005 90006
Access Scientific
Summary: The Wand MicroAccess Safety Introducer is a medical device used for vascular access, primarily by interventional radiologists and vascular surgeons. It facilitates safe and efficient entry into blood vessels.
FDA Clearance Information
Pathway
510K
Number
K081697 ↗
Decision Date
December 4, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Wand MicroAccess Safety Introducer, manufactured by Access Scientific, was cleared via the FDA 510k pathway on December 4, 2008. It is classified as a Class 2 device under product code DYB.
What It Is
The Wand MicroAccess Safety Introducer is a device designed to provide safe vascular access. It typically consists of a needle and sheath system that allows clinicians to access blood vessels with minimal trauma. This device is particularly useful in procedures requiring precise and secure entry into the vascular system, reducing the risk of complications such as vessel damage or bleeding.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures requiring vascular access, such as the placement of embolization coils. It is suitable for use in hospital settings, particularly in catheterization labs or operating rooms. The device is used in adult and pediatric populations requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device involve providing safe and efficient access to blood vessels. It is used in patients who require interventions such as embolization, where precise vascular entry is crucial.
Practical Considerations
The Wand MicroAccess Safety Introducer is available in multiple models to accommodate different vessel sizes and procedural needs. Clinicians should be familiar with the device's compatibility with other vascular access tools and ensure proper technique to minimize complications.
Frequently Asked Questions
What is The Wand MicroAccess Safety Introducer used for?
It is used for providing safe and efficient vascular access, particularly in procedures like embolization.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for safe and efficient access to blood vessels, particularly in procedures requiring precise vascular entry.
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.