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evtool model v 1 0
3D Line U
Summary: The evtool model v 1 0 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 chronic kidney disease.
FDA Clearance Information
Pathway
510K
Number
K013535 ↗
Decision Date
January 18, 2002
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The evtool model v 1 0 was cleared through the FDA 510(k) pathway on January 18, 2002. It is manufactured by 3D Line U and classified as a Class 2 device under product code MUJ.
What It Is
The evtool model v 1 0 is a specialized device designed to assist in the creation and maintenance of vascular access for dialysis. It is typically used to ensure proper blood flow in arteriovenous fistulas or grafts, which are essential for effective hemodialysis. The device may include features that aid in the precise placement and maintenance of these access points, ensuring they remain functional over time.
Clinical Applications
This device is commonly used in settings where dialysis access is created or maintained, such as hospitals and specialized dialysis centers. Nephrologists and vascular surgeons use it during procedures to establish or revise arteriovenous fistulas or grafts in patients with end-stage renal disease. It is crucial for ensuring that patients have reliable access for their dialysis treatments.
Indications for Use
The evtool model v 1 0 is indicated for use in patients requiring vascular access for dialysis. This includes individuals with chronic kidney disease who need regular hemodialysis and require the creation or maintenance of arteriovenous fistulas or grafts.
Practical Considerations
Clinicians should be aware of the device's compatibility with various graft materials and fistula types. It is important to consider the patient's vascular anatomy when selecting the appropriate size and type of device. Proper technique in placement and maintenance is crucial to prevent complications such as thrombosis or infection.
Frequently Asked Questions
What is evtool model v 1 0 used for?
The device is used to assist in the creation and maintenance of vascular access for dialysis, specifically in establishing arteriovenous fistulas or grafts.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device during dialysis access procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients needing vascular access for dialysis, such as those with chronic kidney disease requiring hemodialysis.
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.