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the wand microaccess safety introducer
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 access to blood vessels.
FDA Clearance Information
Pathway
510K
Number
K090372 ↗
Decision Date
March 30, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The WAND MicroAccess Safety Introducer was cleared through the FDA 510(k) pathway on March 30, 2009. Manufactured by Access Scientific, it is a Class 2 device under product code DYB.
What It Is
The WAND MicroAccess Safety Introducer is a specialized device designed to provide safe and efficient vascular access. It incorporates a safety mechanism to minimize the risk of accidental needle sticks and vessel trauma. The device is used to introduce guidewires and catheters into blood vessels, facilitating various diagnostic and therapeutic procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures requiring vascular access, such as angiography, embolization, and catheter placement. It is particularly useful in hospital settings where rapid and safe access to the vascular system is critical. The device is suitable for adult and pediatric patients requiring minimally invasive vascular interventions.
Indications for Use
The FDA-cleared indications for The WAND MicroAccess Safety Introducer include its use in procedures requiring vascular access for the introduction of guidewires and catheters. It is intended for patients needing diagnostic or therapeutic interventions involving the vascular system.
Practical Considerations
The WAND MicroAccess Safety Introducer is available in various sizes to accommodate different vessel diameters and patient anatomies. It is compatible with standard guidewires and catheters. Clinicians should be trained in its use to ensure proper technique and maximize safety benefits.
Frequently Asked Questions
What is The WAND MicroAccess Safety Introducer used for?
It is used for providing safe and efficient vascular access during procedures like angiography and catheter placement.
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 use in procedures requiring vascular access for introducing guidewires and catheters.
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.