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axera 2 access system model axe200
Arstasis
Summary: The Axera 2 Access System by Arstasis is a medical device used to facilitate vascular access, primarily in interventional cardiology and radiology. It is typically employed by clinicians in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K123135 ↗
Decision Date
January 28, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Axera 2 Access System was cleared through the FDA 510(k) pathway on January 28, 2013. Manufactured by Arstasis, it is classified as a Class 2 device under product code DYB.
What It Is
The Axera 2 Access System is a vascular access device designed to improve the efficiency and safety of arterial access during catheter-based procedures. It works by creating a controlled access point in the artery, which can help reduce complications associated with traditional access methods. This device is particularly useful in procedures requiring repeated or complex vascular access.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Axera 2 Access System is employed during procedures such as angiography, stent placement, and embolization. It is particularly beneficial in settings like catheterization labs where quick and reliable arterial access is crucial. The device is suitable for adult patients undergoing these types of procedures.
Indications for Use
The Axera 2 Access System is indicated for patients requiring arterial access for procedures like embolization. It is designed to facilitate safe and efficient access, minimizing the risk of complications.
Practical Considerations
The Axera 2 Access System is compatible with standard catheterization equipment. Clinicians should be familiar with its operation to ensure optimal outcomes. Proper technique is essential to maximize the benefits of this device, and training is recommended for new users.
Frequently Asked Questions
What is the Axera 2 Access System used for?
The Axera 2 Access System is used to facilitate arterial access in procedures like angiography and embolization.
What specialties typically use this device?
Interventional cardiology and radiology specialties typically use the Axera 2 Access System.
What are the FDA-cleared indications?
The device is indicated for arterial access in procedures such as embolization, improving safety and efficiency.
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.