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crossplan accusoft-xl v 4 04
Direx Systems
Summary: The Crossplan Accusoft-XL v 4 04 is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate efficient dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K063482 ↗
Decision Date
December 14, 2006
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Crossplan Accusoft-XL v 4 04 was cleared through the FDA 510(k) pathway on December 14, 2006. Manufactured by Direx Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The Crossplan Accusoft-XL v 4 04 is a specialized device designed to assist in the creation and maintenance of vascular access for dialysis patients. It operates by providing precise imaging and measurement capabilities, which are crucial for planning and executing dialysis access procedures. This device helps clinicians ensure that vascular access is both effective and sustainable, reducing complications and improving patient outcomes.
Clinical Applications
This device is commonly used in clinical settings such as hospitals and specialized dialysis centers. It is particularly valuable in procedures involving the creation of arteriovenous fistulas or grafts. Nephrologists and vascular surgeons rely on it to visualize and assess vascular structures, ensuring that the access points are optimal for dialysis. The device is suitable for adult patients requiring long-term dialysis treatment.
Indications for Use
The FDA indications suggest that the Crossplan Accusoft-XL v 4 04 is intended for use in patients who need vascular access for dialysis. It is particularly beneficial for those undergoing chronic dialysis treatment, requiring precise and reliable access points.
Practical Considerations
Clinicians should be aware of the device's compatibility with standard dialysis equipment and its adaptability to various patient anatomies. Proper training in the device's imaging and measurement functions is essential to maximize its benefits. The device is available in multiple configurations to accommodate different procedural needs.
Frequently Asked Questions
What is Crossplan Accusoft-XL v 4 04 used for?
It is used to assist in the creation and maintenance of vascular access for dialysis patients, ensuring effective and sustainable access points.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for dialysis, particularly those undergoing chronic dialysis treatment.
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.