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axera rx access system
Arstasis
Summary: The Axera RX Access System is a medical device used to gain arterial access in interventional procedures. It is primarily used by interventional cardiologists and radiologists to facilitate vascular access with reduced complications.
FDA Clearance Information
Pathway
510K
Number
K140287 ↗
Decision Date
May 16, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Axera RX Access System was cleared through the FDA 510(k) pathway on May 16, 2014. Manufactured by Arstasis, it is classified as a Class 2 device under product code DYB.
What It Is
The Axera RX Access System is designed to provide arterial access for interventional procedures. It utilizes a unique approach to create a controlled puncture in the artery, aiming to minimize vascular complications such as bleeding. The device is engineered to enhance procedural efficiency and patient safety by providing a reliable and consistent access method.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures requiring vascular access such as angiography, stenting, and embolization. It is suitable for use in hospitals and specialized clinics, catering to adult patients who require arterial access for diagnostic or therapeutic interventions.
Indications for Use
The Axera RX Access System is indicated for patients needing arterial access during interventional procedures. It is particularly beneficial for those undergoing procedures that require precise and safe vascular entry, such as embolization or coil placement.
Practical Considerations
The Axera RX Access System is compatible with standard vascular access equipment and is available in various sizes to accommodate different patient anatomies. Clinicians should be trained in its use to ensure optimal outcomes and minimize potential complications.
Frequently Asked Questions
What is the Axera RX Access System used for?
It is used for gaining arterial access during interventional procedures, such as angiography or stenting.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
It is indicated for arterial access in patients undergoing interventional procedures, aiming to provide a safe and efficient entry point.
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.