đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of percutaneous arterial access for catheter-based procedures.
Clinical Applications
- Obtaining arterial access before angiography or other catheter-based imaging.
- Obtaining arterial access for embolization procedures.
- Obtaining arterial access for endovascular treatment procedures performed in a catheterization or interventional radiology laboratory.
Practical Considerations
- The device is intended for use by trained clinicians familiar with percutaneous arterial access and catheterization procedures.
- The access system should be used with compatible guidewires, sheaths, catheters and other standard equipment according to the current manufacturer instructions for use.
- Access-site selection, vessel caliber, arterial anatomy, anticoagulation status and bleeding risk should be assessed before use.
- The FDA record and supplied information do not establish MRI safety, exact device dimensions or a specific indwelling duration; consult the current labeling for these details.
- Potential access-site complications include bleeding, hematoma, pseudoaneurysm, arterial injury, thrombosis, infection and distal ischemia.
Procedures that use this device
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.