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accusoft
Direx Systems
Summary: Accusoft is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate dialysis treatment in patients with renal failure.
FDA Clearance Information
Pathway
510K
Number
K040474 ↗
Decision Date
June 23, 2004
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Accusoft was cleared through the FDA 510(k) pathway on June 23, 2004. Manufactured by Direx Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
Accusoft is a device designed to aid in the establishment and maintenance of vascular access for dialysis. It works by providing a reliable means to access the bloodstream, which is crucial for patients undergoing hemodialysis. The device ensures efficient and repeated access to the vascular system, minimizing complications associated with dialysis procedures.
Clinical Applications
Accusoft is commonly used in the creation and maintenance of arteriovenous fistulas or grafts, which are essential for hemodialysis. It is typically employed in hospital settings or specialized dialysis centers. The device is used by nephrologists and vascular surgeons, particularly for patients with chronic kidney disease who require long-term dialysis treatment.
Indications for Use
The FDA indications for Accusoft involve its use in facilitating vascular access for dialysis. It is intended for patients who need regular hemodialysis, often due to end-stage renal disease or chronic kidney failure.
Practical Considerations
Accusoft is available in various sizes to accommodate different patient anatomies and access needs. It is compatible with standard dialysis equipment and requires careful handling to ensure proper placement and function. Clinicians should be trained in vascular access techniques to optimize outcomes.
Frequently Asked Questions
What is Accusoft used for?
Accusoft is used to establish and maintain vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use Accusoft in dialysis access procedures.
What are the FDA-cleared indications?
Accusoft is indicated for facilitating vascular access in patients requiring hemodialysis, such as those with chronic kidney failure.
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.